<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03004976</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00077580</org_study_id>
    <nct_id>NCT03004976</nct_id>
  </id_info>
  <brief_title>Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke</brief_title>
  <acronym>CoBIS 2</acronym>
  <official_title>Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke - CoBIS 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joanne Kurtzberg, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Marcus Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine the efficacy of a single intravenous&#xD;
      infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in&#xD;
      patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB&#xD;
      or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or&#xD;
      myeloablative medications prior to the infusion. Subjects will be followed for one year post&#xD;
      infusion for safety and efficacy. Assessments will examine safety and tolerability of the&#xD;
      infusion, change in neurological symptoms, change in quality of life, and emotional and&#xD;
      cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and&#xD;
      365 days post infusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, placebo controlled, randomized, double blinded Phase 2 study in 100&#xD;
      subjects 18-90 years of age who have sustained a recent ischemic stroke. Potential subjects&#xD;
      can be screened and consented the day of their stroke (Day 1). Treatment with umbilical cord&#xD;
      blood (UCB) cells or placebo will be administered intravenously as a single infusion as early&#xD;
      as 3 days but no later than 10 days after the patient's stroke. UCB units will be selected&#xD;
      from an accredited U.S. public cord bank based on blood type, race and a targeted cell dose&#xD;
      ranging between 0.5 to 5 x 10^7 total nucleated cell count (TNCC)/kg. Study subjects will not&#xD;
      receive immunosuppressive or myeloablative medications prior to infusion of the cord blood or&#xD;
      placebo.&#xD;
&#xD;
      All subjects, families and medical staff will be blinded to treatment arm. When a subject is&#xD;
      randomized to study drug at a clinical site without a cord blood bank, the selected cord&#xD;
      blood units (CBU) will be shipped frozen overnight to the site. Once selected and available&#xD;
      on site, each CBU will be thawed, washed, tested, released and infused intravenously using&#xD;
      common standard operating procedures (SOPs) at all sites. For subjects randomized to placebo,&#xD;
      a diluent with the same appearance and odor as a CBU will be prepared.&#xD;
&#xD;
      Patients will have baseline magnetic resonance imaging (MRI) and will be assessed at 1, 3, 6,&#xD;
      and 12 months for functional outcomes. All patients will receive standard of care therapy&#xD;
      while enrolled in this study and all subjects will be strongly encouraged to participate in&#xD;
      rehabilitative therapy.&#xD;
&#xD;
      The primary objective of the study is to determine, in a randomized, placebo controlled&#xD;
      trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for&#xD;
      improving functional outcomes in patients with ischemic stroke. The secondary objectives are&#xD;
      as follows:&#xD;
&#xD;
        1. To describe the safety and tolerability of a single IV infusion of unrelated donor UCB&#xD;
           in patients with ischemic stroke&#xD;
&#xD;
        2. To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement&#xD;
           of neurological symptoms following ischemic stroke&#xD;
&#xD;
        3. To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement&#xD;
           in quality of life and emotional and cognitive status in patients with ischemic stroke&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">March 27, 2021</completion_date>
  <primary_completion_date type="Actual">July 17, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shift in Modified Rankin Scale (mRS)</measure>
    <time_frame>baseline to 3 months post infusion</time_frame>
    <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Infusion Reactions</measure>
    <time_frame>up to 1 year post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Product-related Infections</measure>
    <time_frame>up to 1 year post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Alloimmunization Events</measure>
    <time_frame>up to 1 year post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Graft vs. Host Disease Events</measure>
    <time_frame>up to 1 year post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Study Related and Unexpected Adverse Events (AEs)</measure>
    <time_frame>up to 1 year post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>up to 1 year post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Functional Independence</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion</measure>
    <time_frame>baseline to 30 days post infusion</time_frame>
    <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion</measure>
    <time_frame>baseline to 180 days post infusion</time_frame>
    <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index (BI) Score at 90 Days</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale-16 (SIS-16) Score at 90 Days</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The SIS-16 has a range of 0 to 100 with higher scores indicating a higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The EQ-5D-3L VAS ranges from 0 to 100 with 0 being the worst possible health status and 100 being the best possible health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The PHQ 8 has a range of 0 to 24 with 0 indicating no depression and 24 indicating severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion</measure>
    <time_frame>30 days post infusion</time_frame>
    <description>The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion</measure>
    <time_frame>1 year post infusion</time_frame>
    <description>The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test Score at 90 Days Post Infusion (Trail A)</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Reported in seconds needed to complete Trail A.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test Score at 90 Days Post Infusion (Trail B)</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. Reported in seconds needed to complete Trail B.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The MoCA has a range of 0 to 30 with lower scores indicating more severe cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The HVLT-R is a sum of three trials involving word recall. It has a total range of 0 to 36 with higher scores indicating better recall and greater cognition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>For all sub-components (Physical Functioning, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health), a higher score indicates better health. Scales are standardized to obtain a score ranging from 0 to 100 and a mean score of 50 has been articulated as a normative value for all scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Reported as the total number of words produced for F, A, and S. More words indicates better cognition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion</measure>
    <time_frame>90 days post infusion</time_frame>
    <description>The SDMT is a measure of processing speed wherein the participant is given 120 seconds to orally match symbols with digits as quickly as possible. Reported as the number of correct associations where a larger number indicates better cognition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Stroke</condition>
  <condition>Stroke, Acute</condition>
  <condition>Brain Injury, Acute</condition>
  <arm_group>
    <arm_group_label>Umbilical Cord Blood</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Umbilical Cord Blood</intervention_name>
    <description>Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
    <arm_group_label>Umbilical Cord Blood</arm_group_label>
    <other_name>cord blood</other_name>
    <other_name>hematopoietic stem cells</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-90 years old&#xD;
&#xD;
          2. Recent, acute, cortical, hemispheric, ischemic stroke in the MCA (middle cerebral&#xD;
             artery) distribution without a clinically significant midline shift as detected by MRI&#xD;
             as a DWI (diffusion-weighted imaging) abnormality. If unable to obtain a MRI scan,&#xD;
             patients may be included if there is clear evidence of ischemic cortical involvement&#xD;
             in the MCA distribution demonstrated by computed tomography and a clinical exam&#xD;
             consistent with cortical involvement.&#xD;
&#xD;
          3. NIHSS 6-15 (R) and 6-20 (L) at the time of informed consent. Subjects with a &gt;4-point&#xD;
             increase of NIHSS from time of consent (worsening of score) will not be eligible for&#xD;
             infusion.&#xD;
&#xD;
          4. Subjects must have a platelet count &gt;100,000/uL, hemoglobin &gt;8gm/dL, absolute&#xD;
             lymphocyte count (ALC) ≥ 1200 for African American patients and ≥1500 for all other&#xD;
             racial-ethnic groups, and WBC (white blood cell) count &gt;2,500/uL OR Historical&#xD;
             pre-stroke value of ALC ≥ 1200 for African American and ≥1500 for all other&#xD;
             racial-ethnic groups within 6 months of stroke&#xD;
&#xD;
             -And- a post stroke ALC value of ≥ 1000, platelet count &gt;100,000/uL, hemoglobin&#xD;
             &gt;8gm/dL and WBC &gt;2,500/uL.&#xD;
&#xD;
          5. Subjects who received tPA (Tissue plasminogen Activator) or underwent endovascular&#xD;
             reperfusion may be included in the study&#xD;
&#xD;
          6. Able to provide consent to study or consent is obtained from the patient's legal&#xD;
             representative&#xD;
&#xD;
          7. Subjects of childbearing potential must practice effective contraception during the&#xD;
             study, and be willing to continue contraception for at least 6 months after&#xD;
             intervention so that, in the opinion of the Investigator, they will not become&#xD;
             pregnant during the course of the study&#xD;
&#xD;
          8. Is a good candidate for the trial, in the opinion of the Investigator&#xD;
&#xD;
          9. Agrees to participate in follow-up visits&#xD;
&#xD;
         10. ABO/Rh and race matched CBU(s) with a minimum of 0.5 x 10^7 TNCC/kg based on the&#xD;
             pre-cryopreservation TNCC is available for infusion&#xD;
&#xD;
         11. Has not had a disease or therapy that would compromise current immune function.&#xD;
&#xD;
         12. Has a serum creatinine ≤2 mg/dL OR Glomerular Filtration Rate (GFR) ≥30mL/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        An individual is ineligible to participate if any of the following apply:&#xD;
&#xD;
        Exclusionary Medical Conditions:&#xD;
&#xD;
          1. Medical history of neurological or orthopedic pathology with a deficit as a&#xD;
             consequence that results in a modified Rankin Scale &gt;1 before stroke or has a pre&#xD;
             existing cognitive deficit&#xD;
&#xD;
          2. Clinically significant and/or symptomatic hemorrhage associated with stroke&#xD;
&#xD;
          3. Evidence of significant midline shift as assessed by CT or MRI who are felt to be at&#xD;
             high risk for neurological decompensation or need for decompressive hemicraniectomy&#xD;
             due to hemispheric edema&#xD;
&#xD;
          4. New intracranial hemorrhage, edema, or mass effect that may place patient at increased&#xD;
             risk for secondary deterioration when assessed prior to infusion&#xD;
&#xD;
          5. Hypotension as defined as the need for IV pressor support of SBP (systolic blood&#xD;
             pressure) &lt;90&#xD;
&#xD;
          6. Isolated brain stem stroke&#xD;
&#xD;
          7. Pure lacunar stroke&#xD;
&#xD;
          8. At time of consent, patients who are mechanically ventilated or, at the investigator's&#xD;
             discretion are felt to be likely to need mechanical ventilation are excluded.&#xD;
&#xD;
          9. Requires a craniotomy&#xD;
&#xD;
         10. Serious psychiatric or neurological disease which could alter evaluation on functional&#xD;
             or cognitive scales&#xD;
&#xD;
         11. Active systemic infection that is felt, at the discretion of the Investigator, to&#xD;
             place the patient at increased risk for participation in this study&#xD;
&#xD;
         12. Documentation of human immunodeficiency virus positive (HIV+) status in the medical&#xD;
             record&#xD;
&#xD;
         13. Active malignancy within 3 years prior to the start of screening excluding skin&#xD;
             cancers other than melanoma&#xD;
&#xD;
         14. Known hypercoagulable state or coagulopathy deficiencies such as Factor V Leiden,&#xD;
             Antiphospholipid Syndrome (APC), Protein C, Protein S, anticardiolipin antibody,&#xD;
             phospholipid syndrome or Sickle Cell Disease&#xD;
&#xD;
         15. History of or currently active autoimmune disease, or current immunomodulatory therapy&#xD;
             or a recipient of immunomodulatory therapy in the past year.&#xD;
&#xD;
         16. Concurrent illness or condition that in the opinion of the Investigator might&#xD;
             interfere with treatment or evaluation of safety&#xD;
&#xD;
         17. Current or recent history of alcohol or drug abuse, or stroke associated with drug&#xD;
             abuse that Investigator feels may impair therapy or assessments&#xD;
&#xD;
         18. Pregnant as documented by blood test&#xD;
&#xD;
        Prohibited Concomitant or Prior Therapies&#xD;
&#xD;
          1. Patients currently receiving immunosuppressant drugs, not including glucocorticoid&#xD;
             taper, topical/inhaled glucocorticoids&#xD;
&#xD;
          2. History of prior transfusion reaction&#xD;
&#xD;
          3. Currently on dialysis&#xD;
&#xD;
          4. Recipient of bone marrow or organ transplant&#xD;
&#xD;
          5. Hepatic insufficiency (bilirubin &gt;2.5mg/dL or transaminases &gt;5x the ULN) Patients with&#xD;
             Gilberts syndrome are eligible for study enrollment if other liver function tests are&#xD;
             normal, regardless of bilirubin level&#xD;
&#xD;
          6. Previous or current treatment with angiogenic growth factors, cytokines, gene or stem&#xD;
             cell therapy&#xD;
&#xD;
          7. Participating in another interventional clinical trial of an investigational therapy&#xD;
             within 30 days of consent.&#xD;
&#xD;
        Other Exclusion Criteria&#xD;
&#xD;
          1. Pregnant or lactating women&#xD;
&#xD;
          2. Unable or unwilling to be evaluated for follow-up visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne Kurtzberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <results_first_submitted>July 20, 2022</results_first_submitted>
  <results_first_submitted_qc>September 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 23, 2022</results_first_posted>
  <disposition_first_submitted>May 17, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>September 1, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 23, 2022</disposition_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>Joanne Kurtzberg, MD</investigator_full_name>
    <investigator_title>Director, Robertson Clinical and Translational Cell Therapy Program</investigator_title>
  </responsible_party>
  <keyword>hematopoietic stem cells</keyword>
  <keyword>umbilical cord blood</keyword>
  <keyword>stroke</keyword>
  <keyword>ischemic stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03004976/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Umbilical Cord Blood</title>
          <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 total nucleated cell count (TNCC)/kg.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB (umbilical cord blood) unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Umbilical Cord Blood</title>
          <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="52"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="79"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.3" spread="13.0"/>
                    <measurement group_id="B2" value="64.0" spread="11.1"/>
                    <measurement group_id="B3" value="62.2" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Shift in Modified Rankin Scale (mRS)</title>
        <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
        <time_frame>baseline to 3 months post infusion</time_frame>
        <population>Modified Intention To Treat population (participants who have a baseline and 90 day mRS score)</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Shift in Modified Rankin Scale (mRS)</title>
          <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
          <population>Modified Intention To Treat population (participants who have a baseline and 90 day mRS score)</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Primary efficacy analysis (mRS shift from baseline to 90 days)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.71</p_value>
            <p_value_desc>Wilcoxon Two Sample Test</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Wilcoxon Mann-Whitney Odds</param_type>
            <param_value>0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.248</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Additional analysis of the primary endpoint (mRS score at 90 days), adjusted for baseline mRS, baseline NIHSS, and institution.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.87</p_value>
            <method>Cumulative Logit Proportional Odds Model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.223</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>2.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Infusion Reactions</title>
        <time_frame>up to 1 year post infusion</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infusion Reactions</title>
          <population>Safety population</population>
          <units>reactions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Product-related Infections</title>
        <time_frame>up to 1 year post infusion</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Product-related Infections</title>
          <population>Safety population</population>
          <units>infections</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Alloimmunization Events</title>
        <time_frame>up to 1 year post infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Alloimmunization Events</title>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Graft vs. Host Disease Events</title>
        <time_frame>up to 1 year post infusion</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Graft vs. Host Disease Events</title>
          <population>Safety population</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Study Related and Unexpected Adverse Events (AEs)</title>
        <time_frame>up to 1 year post infusion</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Study Related and Unexpected Adverse Events (AEs)</title>
          <population>Safety population</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <time_frame>up to 1 year post infusion</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <population>Safety population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Functional Independence</title>
        <description>Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intention To Treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Functional Independence</title>
          <description>Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome.</description>
          <population>Modified Intention To Treat population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion</title>
        <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
        <time_frame>baseline to 30 days post infusion</time_frame>
        <population>Modified Intention To Treat population with a 30 day mRS score available</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion</title>
          <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
          <population>Modified Intention To Treat population with a 30 day mRS score available</population>
          <units>shift in score</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion</title>
        <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
        <time_frame>baseline to 180 days post infusion</time_frame>
        <population>Modified Intention To Treat population with a 180 day mRS score available</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion</title>
          <description>The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.</description>
          <population>Modified Intention To Treat population with a 180 day mRS score available</population>
          <units>shift in score</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days</title>
        <description>The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intention To Treat population with NIHSS score available</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days</title>
          <description>The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment.</description>
          <population>Modified Intention To Treat population with NIHSS score available</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="3" upper_limit="9"/>
                    <measurement group_id="O2" value="6" lower_limit="3" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Barthel Index (BI) Score at 90 Days</title>
        <description>The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intention To Treat population with BI available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Barthel Index (BI) Score at 90 Days</title>
          <description>The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence.</description>
          <population>Modified Intention To Treat population with BI available at 90 days</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="50" upper_limit="100"/>
                    <measurement group_id="O2" value="85" lower_limit="45" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stroke Impact Scale-16 (SIS-16) Score at 90 Days</title>
        <description>The SIS-16 has a range of 0 to 100 with higher scores indicating a higher quality of life.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intention to Treat population with SIS-16 score available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Stroke Impact Scale-16 (SIS-16) Score at 90 Days</title>
          <description>The SIS-16 has a range of 0 to 100 with higher scores indicating a higher quality of life.</description>
          <population>Modified Intention to Treat population with SIS-16 score available at 90 days</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" lower_limit="42" upper_limit="76"/>
                    <measurement group_id="O2" value="64" lower_limit="41.5" upper_limit="76.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days</title>
        <description>The EQ-5D-3L VAS ranges from 0 to 100 with 0 being the worst possible health status and 100 being the best possible health status.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intention To Treat population with EQ-5D-3L VAS score available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days</title>
          <description>The EQ-5D-3L VAS ranges from 0 to 100 with 0 being the worst possible health status and 100 being the best possible health status.</description>
          <population>Modified Intention To Treat population with EQ-5D-3L VAS score available at 90 days</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="50" upper_limit="85"/>
                    <measurement group_id="O2" value="75" lower_limit="55" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days</title>
        <description>The PHQ 8 has a range of 0 to 24 with 0 indicating no depression and 24 indicating severe depression.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intention To Treat population with PHQ 8 score available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days</title>
          <description>The PHQ 8 has a range of 0 to 24 with 0 indicating no depression and 24 indicating severe depression.</description>
          <population>Modified Intention To Treat population with PHQ 8 score available at 90 days</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="8"/>
                    <measurement group_id="O2" value="5" lower_limit="2" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion</title>
        <description>The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.</description>
        <time_frame>30 days post infusion</time_frame>
        <population>Modified Intent To Treat population with a TICS score at 30 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion</title>
          <description>The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.</description>
          <population>Modified Intent To Treat population with a TICS score at 30 days</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="19" upper_limit="32"/>
                    <measurement group_id="O2" value="21" lower_limit="10" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion</title>
        <description>The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.</description>
        <time_frame>1 year post infusion</time_frame>
        <population>Modified Intent To Treat population with a TICS score at 1 year</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion</title>
          <description>The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.</description>
          <population>Modified Intent To Treat population with a TICS score at 1 year</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="25" upper_limit="35"/>
                    <measurement group_id="O2" value="30" lower_limit="23" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trail Making Test Score at 90 Days Post Infusion (Trail A)</title>
        <description>Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Reported in seconds needed to complete Trail A.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intent To Treat population with Trail A speed available</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Trail Making Test Score at 90 Days Post Infusion (Trail A)</title>
          <description>Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Reported in seconds needed to complete Trail A.</description>
          <population>Modified Intent To Treat population with Trail A speed available</population>
          <units>seconds</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" lower_limit="56" upper_limit="178"/>
                    <measurement group_id="O2" value="62" lower_limit="44" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trail Making Test Score at 90 Days Post Infusion (Trail B)</title>
        <description>Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. Reported in seconds needed to complete Trail B.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intent To Treat population with Trail B speed available</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Trail Making Test Score at 90 Days Post Infusion (Trail B)</title>
          <description>Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. Reported in seconds needed to complete Trail B.</description>
          <population>Modified Intent To Treat population with Trail B speed available</population>
          <units>seconds</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="278" lower_limit="226" upper_limit="300"/>
                    <measurement group_id="O2" value="300" lower_limit="142" upper_limit="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion</title>
        <description>The MoCA has a range of 0 to 30 with lower scores indicating more severe cognitive impairment.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intent To Treat population with MoCA score available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion</title>
          <description>The MoCA has a range of 0 to 30 with lower scores indicating more severe cognitive impairment.</description>
          <population>Modified Intent To Treat population with MoCA score available at 90 days</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="14.5" upper_limit="24.5"/>
                    <measurement group_id="O2" value="20" lower_limit="8.5" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion</title>
        <description>The HVLT-R is a sum of three trials involving word recall. It has a total range of 0 to 36 with higher scores indicating better recall and greater cognition.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intent To Treat population with HVLT-R scores available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion</title>
          <description>The HVLT-R is a sum of three trials involving word recall. It has a total range of 0 to 36 with higher scores indicating better recall and greater cognition.</description>
          <population>Modified Intent To Treat population with HVLT-R scores available at 90 days</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="9" upper_limit="21"/>
                    <measurement group_id="O2" value="12" lower_limit="8.5" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion</title>
        <description>For all sub-components (Physical Functioning, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health), a higher score indicates better health. Scales are standardized to obtain a score ranging from 0 to 100 and a mean score of 50 has been articulated as a normative value for all scales.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intent To Treat population with SF-36 scores available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion</title>
          <description>For all sub-components (Physical Functioning, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health), a higher score indicates better health. Scales are standardized to obtain a score ranging from 0 to 100 and a mean score of 50 has been articulated as a normative value for all scales.</description>
          <population>Modified Intent To Treat population with SF-36 scores available at 90 days</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="5" upper_limit="70"/>
                    <measurement group_id="O2" value="60" lower_limit="5" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Limitations Due to Physical Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="25"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Limitations Due to Emotional Problems</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy/Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="45" upper_limit="70"/>
                    <measurement group_id="O2" value="65" lower_limit="45" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Well-being</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" lower_limit="56" upper_limit="88"/>
                    <measurement group_id="O2" value="76" lower_limit="64" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5" lower_limit="37.5" upper_limit="87.5"/>
                    <measurement group_id="O2" value="62.5" lower_limit="50.0" upper_limit="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5" lower_limit="55" upper_limit="100"/>
                    <measurement group_id="O2" value="65" lower_limit="42.5" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="50" upper_limit="75"/>
                    <measurement group_id="O2" value="70" lower_limit="50" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion</title>
        <description>The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Reported as the total number of words produced for F, A, and S. More words indicates better cognition.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intent To Treat population with COWAT score available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion</title>
          <description>The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Reported as the total number of words produced for F, A, and S. More words indicates better cognition.</description>
          <population>Modified Intent To Treat population with COWAT score available at 90 days</population>
          <units>words</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="8" upper_limit="32"/>
                    <measurement group_id="O2" value="9.5" lower_limit="6" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion</title>
        <description>The SDMT is a measure of processing speed wherein the participant is given 120 seconds to orally match symbols with digits as quickly as possible. Reported as the number of correct associations where a larger number indicates better cognition.</description>
        <time_frame>90 days post infusion</time_frame>
        <population>Modified Intent To Treat population with SDMT score available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>Umbilical Cord Blood</title>
            <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion</title>
          <description>The SDMT is a measure of processing speed wherein the participant is given 120 seconds to orally match symbols with digits as quickly as possible. Reported as the number of correct associations where a larger number indicates better cognition.</description>
          <population>Modified Intent To Treat population with SDMT score available at 90 days</population>
          <units>associations</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="3" upper_limit="23"/>
                    <measurement group_id="O2" value="21" lower_limit="8" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Umbilical Cord Blood</title>
          <description>A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.&#xD;
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.&#xD;
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>HEART FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>LEFT VENTRICULAR SYSTOLIC DYSFUNCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>COLITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>DEATH NOS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHIAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>ENDOCARDITIS INFECTIVE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SKIN INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>GENERALIZED MUSCLE WEAKNESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>COGNITIVE DISTURBANCE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>INTRACRANIAL HEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>ISCHEMIA CEREBROVASCULAR</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>STROKE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>MUSCLE WEAKNESS RIGHT-SIDED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>CONFUSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>BRONCHIAL OBSTRUCTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DYSPNEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>BULLOUS DERMATITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>THROMBOEMBOLIC EVENT</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANEMIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>LEUKOCYTOSIS</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>CARDIAC DISORDERS - OTHER, SPECIFY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>CHEST PAIN - CARDIAC</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HEART FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>LEFT VENTRICULAR SYSTOLIC DYSFUNCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SINUS BRADYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SINUS TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>VENTRICULAR ARRHYTHMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>CONGENITAL, FAMILIAL AND GENETIC DISORDERS - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>ENDOCRINE DISORDERS - OTHER, SPECIFY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>EYE PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DIARRHEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DYSPHAGIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>ESOPHAGITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>FLATULENCE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>GASTRIC ULCER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL DISORDERS - OTHER, SPECIFY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>ILEUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>MUCOSITIS ORAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>OBSTRUCTION GASTRIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>EDEMA LIMBS</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>FEVER</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BACTEREMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DEVICE RELATED INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HEPATITIS B REACTIVATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>LUNG INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>VAGINAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>CARDIAC TROPONIN T INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>INVESTIGATIONS - OTHER, SPECIFY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>URINE OUTPUT DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>ANOREXIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPERGLYCEMIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPERKALEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPERNATREMIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPERURICEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPOCALCEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPOKALEMIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPONATREMIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIF</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>COGNITIVE DISTURBANCE</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>CONCENTRATION IMPAIRMENT</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>INTRACRANIAL HEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>ISCHEMIA CEREBROVASCULAR</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>PERIPHERAL MOTOR NEUROPATHY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SENSORY NEUROPATHY</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SPASTICITY</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DELAYED ORGASM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>PERSONALITY CHANGE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DYSURIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HEMATURIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>URINARY INCONTINENCE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>MENORRHAGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>PROSTATIC OBSTRUCTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER,</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>BRONCHIAL OBSTRUCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>APNEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>DYSPNEA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>PULMONARY EDEMA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS -</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PAIN OF SKIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>RASH MACULO-PAPULAR</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SP</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SKIN ULCERATION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>THROMBOEMBOLIC EVENT</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Emily Poehlein, MB</name_or_title>
      <organization>Duke University</organization>
      <phone>919-668-8473</phone>
      <email>emily.poehlein@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004976
org study id: Pro00077580
nct id: NCT03004976
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to determine the efficacy of a single intravenous
      infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in
      patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB
      or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or
      myeloablative medications prior to the infusion. Subjects will be followed for one year post
      infusion for safety and efficacy. Assessments will examine safety and tolerability of the
      infusion, change in neurological symptoms, change in quality of life, and emotional and
      cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and
      365 days post infusion.
This is a multicenter, placebo controlled, randomized, double blinded Phase 2 study in 100
      subjects 18-90 years of age who have sustained a recent ischemic stroke. Potential subjects
      can be screened and consented the day of their stroke (Day 1). Treatment with umbilical cord
      blood (UCB) cells or placebo will be administered intravenously as a single infusion as early
      as 3 days but no later than 10 days after the patient's stroke. UCB units will be selected
      from an accredited U.S. public cord bank based on blood type, race and a targeted cell dose
      ranging between 0.5 to 5 x 10^7 total nucleated cell count (TNCC)/kg. Study subjects will not
      receive immunosuppressive or myeloablative medications prior to infusion of the cord blood or
      placebo.

      All subjects, families and medical staff will be blinded to treatment arm. When a subject is
      randomized to study drug at a clinical site without a cord blood bank, the selected cord
      blood units (CBU) will be shipped frozen overnight to the site. Once selected and available
      on site, each CBU will be thawed, washed, tested, released and infused intravenously using
      common standard operating procedures (SOPs) at all sites. For subjects randomized to placebo,
      a diluent with the same appearance and odor as a CBU will be prepared.

      Patients will have baseline magnetic resonance imaging (MRI) and will be assessed at 1, 3, 6,
      and 12 months for functional outcomes. All patients will receive standard of care therapy
      while enrolled in this study and all subjects will be strongly encouraged to participate in
      rehabilitative therapy.

      The primary objective of the study is to determine, in a randomized, placebo controlled
      trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for
      improving functional outcomes in patients with ischemic stroke. The secondary objectives are
      as follows:

        1. To describe the safety and tolerability of a single IV infusion of unrelated donor UCB
           in patients with ischemic stroke

        2. To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement
           of neurological symptoms following ischemic stroke

        3. To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement
           in quality of life and emotional and cognitive status in patients with ischemic stroke
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Shift in Modified Rankin Scale (mRS)
time frame: baseline to 3 months post infusion
description: The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
measure: Number of Infusion Reactions
time frame: up to 1 year post infusion
measure: Number of Product-related Infections
time frame: up to 1 year post infusion
measure: Number of Alloimmunization Events
time frame: up to 1 year post infusion
measure: Number of Graft vs. Host Disease Events
time frame: up to 1 year post infusion
measure: Number of Study Related and Unexpected Adverse Events (AEs)
time frame: up to 1 year post infusion
measure: Mortality
time frame: up to 1 year post infusion
measure: Number of Participants With Functional Independence
time frame: 90 days post infusion
description: Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome.
measure: Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion
time frame: baseline to 30 days post infusion
description: The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
measure: Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion
time frame: baseline to 180 days post infusion
description: The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
measure: The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days
time frame: 90 days post infusion
description: The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment.
measure: Barthel Index (BI) Score at 90 Days
time frame: 90 days post infusion
description: The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence.
measure: Stroke Impact Scale-16 (SIS-16) Score at 90 Days
time frame: 90 days post infusion
description: The SIS-16 has a range of 0 to 100 with higher scores indicating a higher quality of life.
measure: The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days
time frame: 90 days post infusion
description: The EQ-5D-3L VAS ranges from 0 to 100 with 0 being the worst possible health status and 100 being the best possible health status.
measure: Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days
time frame: 90 days post infusion
description: The PHQ 8 has a range of 0 to 24 with 0 indicating no depression and 24 indicating severe depression.
measure: Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion
time frame: 30 days post infusion
description: The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.
measure: Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion
time frame: 1 year post infusion
description: The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.
measure: Trail Making Test Score at 90 Days Post Infusion (Trail A)
time frame: 90 days post infusion
description: Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Reported in seconds needed to complete Trail A.
measure: Trail Making Test Score at 90 Days Post Infusion (Trail B)
time frame: 90 days post infusion
description: Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. Reported in seconds needed to complete Trail B.
measure: Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion
time frame: 90 days post infusion
description: The MoCA has a range of 0 to 30 with lower scores indicating more severe cognitive impairment.
measure: Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion
time frame: 90 days post infusion
description: The HVLT-R is a sum of three trials involving word recall. It has a total range of 0 to 36 with higher scores indicating better recall and greater cognition.
measure: Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
time frame: 90 days post infusion
description: For all sub-components (Physical Functioning, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health), a higher score indicates better health. Scales are standardized to obtain a score ranging from 0 to 100 and a mean score of 50 has been articulated as a normative value for all scales.
measure: Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion
time frame: 90 days post infusion
description: The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Reported as the total number of words produced for F, A, and S. More words indicates better cognition.
measure: Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion
time frame: 90 days post infusion
description: The SDMT is a measure of processing speed wherein the participant is given 120 seconds to orally match symbols with digits as quickly as possible. Reported as the number of correct associations where a larger number indicates better cognition.
arm group label: Umbilical Cord Blood
arm group type: Experimental
description: A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
arm group label: Placebo
arm group type: Placebo Comparator
description: A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
intervention type: Biological
intervention name: Umbilical Cord Blood
description: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.
arm group label: Umbilical Cord Blood
other name: cord blood
other name: hematopoietic stem cells
intervention type: Other
intervention name: Placebo
description: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Joanne Kurtzberg, MD
role: Principal Investigator
affiliation: Duke University
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country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Duke University
investigator full name: Joanne Kurtzberg, MD
investigator title: Director, Robertson Clinical and Translational Cell Therapy Program
mesh term: Stroke
mesh term: Brain Injuries
mesh term: Ischemic Stroke
sharing ipd: No
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