<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/NCT01714167</url>
  </required_header>
  <id_info>
    <org_study_id>WZMC-2011-8</org_study_id>
    <nct_id>NCT01714167</nct_id>
  </id_info>
  <brief_title>Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke</brief_title>
  <official_title>Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Texas Health Science Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is one of the leading causes of disability in the world, and stem cell -&#xD;
      transplantation provides a promising approach for rehabilitation. The main objective of this&#xD;
      study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow&#xD;
      mesenchymal stem cells in patients with chronic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by&#xD;
      a life-long process of clinical support. However, even with rehabilitation therapy, 50% to&#xD;
      95% of stroke survivors remain impaired. There is thus a great need for new therapeutic&#xD;
      developments for patients with disability after stroke, which is largely unexplored.&#xD;
      Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem&#xD;
      cells might be possible for dead or injured neural cells to be replaced after acute stroke.&#xD;
      In this study, the investigators will assess the safety and feasibility of intracerebral&#xD;
      transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic&#xD;
      stroke. The neurological outcome will be determined after transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in NIH Stroke Scale at 12 months</measure>
    <time_frame>1, 6 and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of infarct size measured by brain MRI</measure>
    <time_frame>1,6 and 12 months after transplantation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>intracerebral stem cell transplantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group receive conventional stroke treatment that include rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>intracerebral stem cell transplantation</intervention_name>
    <description>Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient</description>
    <arm_group_label>intracerebral stem cell transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 40-70 ischemia stroke or intracerebral hemorrhage patient&#xD;
&#xD;
          -  With stroke history of more than 3 months, less than 60 months&#xD;
&#xD;
          -  With stable hemiplegia condition&#xD;
&#xD;
          -  NIHSS (NIH stroke scale) score of 7 or more points&#xD;
&#xD;
          -  Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure&#xD;
             of 125 mm of Hg, fasting blood sugar &lt;7 mg, and normal urea/electrolytes for at least&#xD;
             48 hours.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged less than 40 or more than 70&#xD;
&#xD;
          -  Lacunar infarction&#xD;
&#xD;
          -  History of neurological disease, head injury or psychiatric disorder with disablity&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or&#xD;
             special condition&#xD;
&#xD;
          -  Inaccessibility for follow up&#xD;
&#xD;
          -  Unwillingness to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kunlin Jin, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>University of North Texas Health Science Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qichuan Zhuge, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qichuan Zhuge, M.D.</last_name>
    <email>zhugeqichuan@vip.163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>32500</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>June 4, 2015</last_update_submitted>
  <last_update_submitted_qc>June 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Qichuan Zhuge</investigator_full_name>
    <investigator_title>Department of Neurosurgery</investigator_title>
  </responsible_party>
  <keyword>Chronic</keyword>
  <keyword>Ischemic Stroke</keyword>
  <keyword>Intracerebral Hemorrhage</keyword>
  <keyword>Bone Marrow Mesenchymal Stem Cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT01714167
org study id: WZMC-2011-8
nct id: NCT01714167
lead sponsor: 
collaborator: 
has dmc: Yes
Stroke is one of the leading causes of disability in the world, and stem cell -
      transplantation provides a promising approach for rehabilitation. The main objective of this
      study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow
      mesenchymal stem cells in patients with chronic stroke.
For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by
      a life-long process of clinical support. However, even with rehabilitation therapy, 50% to
      95% of stroke survivors remain impaired. There is thus a great need for new therapeutic
      developments for patients with disability after stroke, which is largely unexplored.
      Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem
      cells might be possible for dead or injured neural cells to be replaced after acute stroke.
      In this study, the investigators will assess the safety and feasibility of intracerebral
      transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic
      stroke. The neurological outcome will be determined after transplantation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in NIH Stroke Scale at 12 months
time frame: 1, 6 and 12 months
measure: Improvement of infarct size measured by brain MRI
time frame: 1,6 and 12 months after transplantation
arm group label: intracerebral stem cell transplantation
arm group type: Active Comparator
description: Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation
arm group label: conventional treatment
arm group type: No Intervention
description: Control group receive conventional stroke treatment that include rehabilitation
intervention type: Genetic
intervention name: intracerebral stem cell transplantation
description: Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient
arm group label: intracerebral stem cell transplantation
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kunlin Jin, M.D., Ph.D.
role: Study Director
affiliation: University of North Texas Health Science Center
last name: Qichuan Zhuge, M.D.
role: Study Chair
affiliation: First Affiliated Hospital of Wenzhou Medical University
last name: Qichuan Zhuge, M.D.
email: zhugeqichuan@vip.163.com
facility: 
status: Recruiting
country: China
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Qichuan Zhuge
investigator title: Department of Neurosurgery
mesh term: Stroke