<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/NCT02237547</url>
  </required_header>
  <id_info>
    <org_study_id>CNEI-2014-TBS-UCMSC-SCI001</org_study_id>
    <nct_id>NCT02237547</nct_id>
  </id_info>
  <brief_title>Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury</brief_title>
  <official_title>Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Translational Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Translational Biosciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear&#xD;
      Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected&#xD;
      intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will assess primary safety and secondary efficacy endpoints of autologous&#xD;
      bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem&#xD;
      cells administered to 20 male and female subjects between ages of 18-50 with spinal cord&#xD;
      injury. These cells will be administered intrathecally and intravenously multiple times over&#xD;
      the course of one month.&#xD;
&#xD;
      The primary objective is freedom from treatment-associated adverse events at 3 and 12 months&#xD;
      post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and&#xD;
      will be quantified based on the following: American Spinal Cord Injury Association (ASIA)&#xD;
      classification and the Frankel Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No enrollment.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>12 weeks, 52 weeks</time_frame>
    <description>12 and 52 weeks after final treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline</measure>
    <time_frame>12 weeks, 52 weeks</time_frame>
    <description>12 and 52 weeks after final treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with a change in Frankel Scale score from baseline</measure>
    <time_frame>12 weeks, 52 weeks</time_frame>
    <description>12 and 52 weeks from final treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>IV and IT UC-MSC and BMMC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells</intervention_name>
    <arm_group_label>IV and IT UC-MSC and BMMC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women between age 18 and 50&#xD;
&#xD;
          -  Paraplegics and quadriplegics with complete or incomplete spinal cord injuries.&#xD;
&#xD;
          -  Willingness to undergo bone marrow derived autologous cell therapy.&#xD;
&#xD;
          -  Ability and willingness to make regular visits to hospital and follow ups during the&#xD;
             protocol procedure and comply with all medical instructions&#xD;
&#xD;
          -  Traumatic Injury of spinal cord with complete or partial damage by Magnetic Resonance&#xD;
             Imaging (MRI) and injury level below C4&#xD;
&#xD;
          -  ASIA impairment scale from A - C&#xD;
&#xD;
          -  Must have proof of health insurance in country of residence.&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre- existing or current systemic disease such as lung, liver (exception: history of&#xD;
             uncomplicated hepatitis A), gastrointestinal, cardiac, Human Immunodeficiency Virus&#xD;
             (HIV)&#xD;
&#xD;
          -  History of life threatening allergic- or immune-mediated reaction&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Peripheral muscular dystrophy&#xD;
&#xD;
          -  Lactating or pregnant woman&#xD;
&#xD;
          -  Women capable of childbearing unwilling to use multiple forms of contraception&#xD;
&#xD;
          -  Alcohol drug abuse /dependence&#xD;
&#xD;
          -  Positive test result for hepatitis A and Hepatitis B OR C&#xD;
&#xD;
          -  Major-traumatic brain injury and psychiatric illness&#xD;
&#xD;
          -  Open injuries&#xD;
&#xD;
          -  Active infectious diseases&#xD;
&#xD;
          -  Life expectancy of less than one year due to terminal condition&#xD;
&#xD;
          -  Neurodegenerative diseases&#xD;
&#xD;
          -  Primary hematologic diseases&#xD;
&#xD;
          -  Any of the following medications that cannot be discontinued one week prior to the&#xD;
             first stem cell administration and throughout the course of treatment. (1 week before&#xD;
             visit 2 through one week after visit 12)&#xD;
&#xD;
               -  Antibiotics&#xD;
&#xD;
               -  Antifungals&#xD;
&#xD;
               -  Antivirals&#xD;
&#xD;
               -  Blood thinners (to avoid bleeding risk during bone marrow aspiration and IT&#xD;
                  procedures)&#xD;
&#xD;
               -  High doses of Vitamin D or fish oils (since these might prolong bleeding times)&#xD;
&#xD;
          -  Bone reflecting increased risk for spinal puncture&#xD;
&#xD;
          -  Hepatic dysfunction&#xD;
&#xD;
          -  Other medical complications that contraindicate surgery, including major respiratory&#xD;
             complications&#xD;
&#xD;
          -  Participation in another clinical trial&#xD;
&#xD;
          -  Coagulopathies&#xD;
&#xD;
          -  Uncorrected coagulopathy during the baseline period defined as: International&#xD;
             Normalized Ratio (INR) &gt; 1.4; Partial Thromboplastin Time (PTT) &gt; 35 sec; Platelet&#xD;
             Count (PLT) &lt; 100,000.&#xD;
&#xD;
          -  Pre-injury history of seizure disorder and/or neurological impairment where&#xD;
             participation in age-appropriate pain rating scales would not be practical or possible&#xD;
&#xD;
          -  Subject does not sign informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nelson Novarro, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Stem Cell Institute</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Panama</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spinal cord injury</keyword>
  <keyword>mesenchymal</keyword>
  <keyword>bone marrow</keyword>
  <keyword>mononuclear cells</keyword>
  <keyword>stem cells</keyword>
  <keyword>umbilical cord</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02237547
org study id: CNEI-2014-TBS-UCMSC-SCI001
nct id: NCT02237547
lead sponsor: 
has dmc: Yes
Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear
      Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected
      intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.
The proposed study will assess primary safety and secondary efficacy endpoints of autologous
      bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem
      cells administered to 20 male and female subjects between ages of 18-50 with spinal cord
      injury. These cells will be administered intrathecally and intravenously multiple times over
      the course of one month.

      The primary objective is freedom from treatment-associated adverse events at 3 and 12 months
      post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and
      will be quantified based on the following: American Spinal Cord Injury Association (ASIA)
      classification and the Frankel Scale.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with adverse events
time frame: 12 weeks, 52 weeks
description: 12 and 52 weeks after final treatment
measure: Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline
time frame: 12 weeks, 52 weeks
description: 12 and 52 weeks after final treatment
measure: Number of subjects with a change in Frankel Scale score from baseline
time frame: 12 weeks, 52 weeks
description: 12 and 52 weeks from final treatment
arm group label: IV and IT UC-MSC and BMMC
arm group type: Experimental
description: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
intervention type: Biological
intervention name: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
arm group label: IV and IT UC-MSC and BMMC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nelson Novarro, MD
role: Principal Investigator
facility: 
country: Panama
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries