<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/NCT03291366</url>
  </required_header>
  <id_info>
    <org_study_id>MSC-CNS2017</org_study_id>
    <nct_id>NCT03291366</nct_id>
  </id_info>
  <brief_title>Mesenchymal Stem Cells in Central Nervous System injury2017</brief_title>
  <official_title>Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System injury2017</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuzhou General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fuzhou General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Central nervous system (CNS) injury leads to morbidity in patients, which has few good&#xD;
      rehabilitation measures. Mesenchymal stem cells seem to have regenerative and&#xD;
      tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem&#xD;
      cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by&#xD;
      recording the change of nervous system scores, trying to prove the effect of MSC in&#xD;
      rehabilitate CNS injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>life quality score</measure>
    <time_frame>1y</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>1y</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Central Nervous System Injury</condition>
  <arm_group>
    <arm_group_label>MSC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>infusion of aUCMSC and conventional therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UCMSCC</intervention_name>
    <description>infusion of aUCMSC and conventional therapy</description>
    <arm_group_label>MSC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>conventional treatment</intervention_name>
    <description>conventional treatment</description>
    <arm_group_label>MSC</arm_group_label>
    <arm_group_label>conventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CNS injury &gt; 3 months&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  willing to give consent&#xD;
&#xD;
          -  stable vital signs&#xD;
&#xD;
          -  absence of active infectcion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any contradiction to intrathecal infusion&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  CNS injury &lt; 3 months&#xD;
&#xD;
          -  CNS injury &gt; 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fuzhou General Hospital</investigator_affiliation>
    <investigator_full_name>Jianming Tan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trauma, Nervous System</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03291366
org study id: MSC-CNS2017
nct id: NCT03291366
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Central nervous system (CNS) injury leads to morbidity in patients, which has few good
      rehabilitation measures. Mesenchymal stem cells seem to have regenerative and
      tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem
      cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by
      recording the change of nervous system scores, trying to prove the effect of MSC in
      rehabilitate CNS injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: life quality score
time frame: 1y
measure: adverse events
time frame: 1y
arm group label: MSC
arm group type: Experimental
description: infusion of aUCMSC and conventional therapy
arm group label: conventional
arm group type: Active Comparator
description: conventional therapy
intervention type: Drug
intervention name: UCMSCC
description: infusion of aUCMSC and conventional therapy
arm group label: MSC
intervention type: Drug
intervention name: conventional treatment
description: conventional treatment
arm group label: MSC
arm group label: conventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Fuzhou General Hospital
investigator full name: Jianming Tan
investigator title: Professor
mesh term: Trauma, Nervous System
mesh term: Wounds and Injuries
sharing ipd: No