<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/NCT02241434</url>
  </required_header>
  <id_info>
    <org_study_id>NGBSI-13</org_study_id>
    <nct_id>NCT02241434</nct_id>
  </id_info>
  <brief_title>Stem Cell Therapy in Duchenne Muscular Dystrophy</brief_title>
  <official_title>The Role of Autologous Bone Marrow Mononuclear Cell Therapy in Duchenne Muscular Dystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurogen Brain and Spine Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurogen Brain and Spine Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to study the effect of stem cell therapy in patients with&#xD;
      Duchenne Muscular Dystrophy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 1</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>Manual Muscle Testing</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brooke and Vignos Scale</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Duchenne Muscular Dystrophy</condition>
  <arm_group>
    <arm_group_label>Stem Cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bone marrow mononuclear cell transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Stem Cell</intervention_name>
    <description>Intrathecal autologous bone marrow mononuclear cell transplantation</description>
    <arm_group_label>Stem Cell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age group of 3-25 years&#xD;
&#xD;
          -  Duchenne muscular dystrophy diagnosed on the basis of clinical presentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of respiratory distress&#xD;
&#xD;
          -  presence of acute infections such as Human Immunodeficient Virus/Hepatitis B&#xD;
             Virus/Hepatitis C Virus&#xD;
&#xD;
          -  malignancies&#xD;
&#xD;
          -  acute medical conditions such as respiratory infection, fever, hemoglobin less than 8,&#xD;
             bleeding tendency, bone marrow disorder, left ventricular ejection fraction &lt; 30%&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Neurogen brain and spine institute</name>
      <address>
        <city>Navi Mumbai</city>
        <state>Maharashtra</state>
        <zip>400706</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Duchenne muscular dystrophy</keyword>
  <keyword>Autologous Bone marrow Mononuclear cell therapy</keyword>
  <keyword>Stem Cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Muscular Dystrophy, Duchenne</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/NCT02241434
org study id: NGBSI-13
nct id: NCT02241434
lead sponsor: 
has dmc: Yes
The purpose of this study was to study the effect of stem cell therapy in patients with
      Duchenne Muscular Dystrophy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Manual Muscle Testing
time frame: 1 year
measure: Brooke and Vignos Scale
time frame: 1 year
arm group label: Stem Cell
arm group type: Experimental
description: bone marrow mononuclear cell transplantation
intervention type: Biological
intervention name: Stem Cell
description: Intrathecal autologous bone marrow mononuclear cell transplantation
arm group label: Stem Cell
criteria: 
gender: All
minimum age: 3 Years
maximum age: 25 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor
mesh term: Muscular Dystrophies
mesh term: Muscular Dystrophy, Duchenne