<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/NCT01673932</url>
  </required_header>
  <id_info>
    <org_study_id>UCB-IS-01</org_study_id>
    <nct_id>NCT01673932</nct_id>
  </id_info>
  <brief_title>Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke</brief_title>
  <official_title>Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Spinal Cord Injury Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Prince of Wales Hospital, Shatin, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen Mary Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>StemCyte, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>China Spinal Cord Injury Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear&#xD;
      cells (UCBMC) treatment of chronic ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, delayed-treatment trial.&#xD;
&#xD;
      A total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and&#xD;
      randomly assigned into two treatment group. Group A (early-treatment group) will receive&#xD;
      transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. Group B&#xD;
      (delayed-treatment group) will participate in 6 months observation before the UCBMC&#xD;
      transplantation at Month 6. All subjects will be followed up for 18 months from enrollment at&#xD;
      Day 0. Long-term follow-up will be carried up to 36 months if applicable.&#xD;
&#xD;
      The adverse events and safety parameters will be collected and recorded. In addition, the&#xD;
      stroke scores , gait and brain MRI will be obtained before and after the treatment to assess&#xD;
      the safety and potential treatment effect of UCBMC in chronic ischemic stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>National Institutes of Health Stroke Scale</measure>
    <time_frame>18 months, up to 36 months</time_frame>
    <description>The change from the baseline in National Institutes of Health Stroke Scales</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>European Stroke Scale (ESS)</measure>
    <time_frame>18 months, up to 36 months if applicable</time_frame>
    <description>The change from baseline in ESS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Min-Mental State Examination (MMSE)</measure>
    <time_frame>18 months</time_frame>
    <description>The change from baseline in MMSE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI</measure>
    <time_frame>18 months</time_frame>
    <description>The change in MRI between pre-treatment and post-treatment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.</measure>
    <time_frame>18 months, up to 36 months follow-up</time_frame>
    <description>Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Stroke</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Brain Ischemia</condition>
  <arm_group>
    <arm_group_label>Group A - UCBMC Early Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - UCBMC Delayed Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UCBMC</intervention_name>
    <description>Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site</description>
    <arm_group_label>Group A - UCBMC Early Treatment Group</arm_group_label>
    <arm_group_label>Group B - UCBMC Delayed Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery</intervention_name>
    <arm_group_label>Group A - UCBMC Early Treatment Group</arm_group_label>
    <arm_group_label>Group B - UCBMC Delayed Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  either gender, age 35 -65 years old;&#xD;
&#xD;
          -  ischemic stroke &gt; 6 months and &lt; 60 months;&#xD;
&#xD;
          -  stable hemiplegia or hemiparesis condition &gt; 3 months;&#xD;
&#xD;
          -  stroke-induced clinical deficits affecting motor, perceptual, or language functions,&#xD;
             with NIHSS of 5-15;&#xD;
&#xD;
          -  stroke in the middle cerebral artery territory;&#xD;
&#xD;
          -  subjects able to understand, sign and date the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or&#xD;
             intraventricular hemorrhage;&#xD;
&#xD;
          -  pregnant or lactating women;&#xD;
&#xD;
          -  alcohol or drug abuse in previous 3 months;&#xD;
&#xD;
          -  significant medical diseases or infections;&#xD;
&#xD;
          -  current participation in another investigational study or taking any investigational&#xD;
             drug within last 4 weeks before the screening;&#xD;
&#xD;
          -  unavailability of HLA-matched umbilical cord blood unit;&#xD;
&#xD;
          -  investigator suggests that the subject would not suitable to perform the surgery or&#xD;
             participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waisang Poon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Chinese University of Hong Kong, Prince of Wales Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gilberto Ka Kit Leung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong, Queen Mary Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karrie Kiang</last_name>
      <phone>+852 2255 4468</phone>
      <email>mykiang@hku.hk</email>
    </contact>
    <investigator>
      <last_name>Gilberto Ka Kit Leung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Waisang Poon, MD</last_name>
      <phone>+852 2632 1625</phone>
      <email>stroke-study@surgery.cuhk.edu.hk</email>
    </contact>
    <investigator>
      <last_name>Waisang Poon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>chronic stroke</keyword>
  <keyword>ischemic stroke</keyword>
  <keyword>umbilical cord blood</keyword>
  <keyword>mononuclear cell</keyword>
  <keyword>transplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Ischemia</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/NCT01673932
org study id: UCB-IS-01
nct id: NCT01673932
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear
      cells (UCBMC) treatment of chronic ischemic stroke.
This is an open-label, delayed-treatment trial.

      A total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and
      randomly assigned into two treatment group. Group A (early-treatment group) will receive
      transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. Group B
      (delayed-treatment group) will participate in 6 months observation before the UCBMC
      transplantation at Month 6. All subjects will be followed up for 18 months from enrollment at
      Day 0. Long-term follow-up will be carried up to 36 months if applicable.

      The adverse events and safety parameters will be collected and recorded. In addition, the
      stroke scores , gait and brain MRI will be obtained before and after the treatment to assess
      the safety and potential treatment effect of UCBMC in chronic ischemic stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: National Institutes of Health Stroke Scale
time frame: 18 months, up to 36 months
description: The change from the baseline in National Institutes of Health Stroke Scales
measure: European Stroke Scale (ESS)
time frame: 18 months, up to 36 months if applicable
description: The change from baseline in ESS
measure: Barthel Index
time frame: 18 months
measure: Min-Mental State Examination (MMSE)
time frame: 18 months
description: The change from baseline in MMSE
measure: MRI
time frame: 18 months
description: The change in MRI between pre-treatment and post-treatment
measure: Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
time frame: 18 months, up to 36 months follow-up
description: Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
arm group label: Group A - UCBMC Early Treatment Group
arm group type: Experimental
description: Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
arm group label: Group B - UCBMC Delayed Treatment Group
arm group type: Experimental
description: Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
intervention type: Biological
intervention name: UCBMC
description: Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
arm group label: Group A - UCBMC Early Treatment Group
arm group label: Group B - UCBMC Delayed Treatment Group
intervention type: Procedure
intervention name: surgery
arm group label: Group A - UCBMC Early Treatment Group
arm group label: Group B - UCBMC Delayed Treatment Group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
last name: Waisang Poon, MD
role: Principal Investigator
affiliation: The Chinese University of Hong Kong, Prince of Wales Hospital
last name: Gilberto Ka Kit Leung, MD
role: Principal Investigator
affiliation: The University of Hong Kong, Queen Mary Hospital
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Brain Ischemia
mesh term: Ischemia