<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/NCT01730183</url>
  </required_header>
  <id_info>
    <org_study_id>TPSC/POC/BMSC/SCI</org_study_id>
    <nct_id>NCT01730183</nct_id>
    <nct_alias>NCT01490242</nct_alias>
  </id_info>
  <brief_title>To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury</brief_title>
  <acronym>ABSCI</acronym>
  <official_title>To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Max Institute of Neurosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Max Institute of Neurosciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate&#xD;
      the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal&#xD;
      cord injury patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that&#xD;
      usually leads to severe and permanent paralysis and the projected data related to the burden&#xD;
      of spinal cord injuries across the globe is quite alarming. Pharmacological and&#xD;
      rehabilitation therapies to SCI have got limited effect. There is definitely an urgent need&#xD;
      for finding different methods of treatment for these patients who cannot undergo established&#xD;
      modalities of treatment or these have been tried unsuccessfully. Another promising&#xD;
      therapeutic approach for SCI is &quot;Stem cell transplantation&quot;. Bone marrow derived stem cells&#xD;
      have been shown to promote anatomical and functional recovery in animal models of SCI by&#xD;
      promoting tissue sparing, axonal regeneration, and remyelination. In our present study, we&#xD;
      want to evaluate the safety and efficacy of autologous bone marrow derived stem cells&#xD;
      surgically transplanted intrathecally into patients with spinal cord injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</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 participants with adverse events as a measure of safety and tolerability.</measure>
    <time_frame>18 months</time_frame>
    <description>The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.</measure>
    <time_frame>18 months</time_frame>
    <description>Improvement in the functional Independence as measured by Spinal Cord Independence Measure (SCIM III). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]&#xD;
Improvement in the pain sensation score as measured by Bryce/Ragnarsson SCI pain taxonomy (BR-SCI-PT). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]&#xD;
Significant Changes in the muscle tone as indicated by Modified Ashworth Scale (MAS). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]&#xD;
Improvement in the Clinical Outcome Variable Scale (COVS) score. [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Bone marrow derived stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bone marrow derived stem cells</intervention_name>
    <description>Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.</description>
    <arm_group_label>Bone marrow derived stem cells</arm_group_label>
    <other_name>Bone Marrow derived Mononucleated stem cell (BMMNCs)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Traumatic injury of the spinal cord (below C5 level) occurring within 6 months to 8&#xD;
             years prior to treatment, resulting in a sustained and complete / Partial loss of&#xD;
             sensory and motor function below the injury (ASIA Category A, B and C ).&#xD;
&#xD;
          2. Confirmation spinal cord injury level (Patients with complete or partial&#xD;
             transection/damage by MRI).&#xD;
&#xD;
          3. Those provide fully informed consent.&#xD;
&#xD;
          4. The level of spinal cord injury must be below C4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Spinal vertebral instability.&#xD;
&#xD;
          2. Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)&#xD;
&#xD;
          3. ASIA Impairment Scale category other than D &amp; E.&#xD;
&#xD;
          4. Lactating and pregnant women.&#xD;
&#xD;
          5. Syringomyelia is also an exclusion criterion but an exemption can be made for a&#xD;
             patient with a stable syrinx.&#xD;
&#xD;
          6. Platelet count greater than 100 thousand/µl at screening.&#xD;
&#xD;
          7. Hematocrit less than 30% prior to bone marrow aspiration.&#xD;
&#xD;
          8. Patients with major and current psychiatric illness.&#xD;
&#xD;
          9. Significant traumatic brain injury associated with the spinal cord injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yashbir Dewan, MS, MCh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Max Healthcare</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yashbir Dewan, MS, MCh</last_name>
    <role>Study Chair</role>
    <affiliation>Max Helathcare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yashbir Dewan, MS, MCh</last_name>
    <phone>+91-8800255922</phone>
    <email>dr.ydewanneuro@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Max Super speciality Hospital</name>
      <address>
        <city>Dehradun</city>
        <state>Uttrakhand</state>
        <zip>248001</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>+91-8800255922</phone>
      <email>dr.ydewanneuro@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Yashbir Dewan, MS, MCh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.</citation>
    <PMID>19364066</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 15, 2012</last_update_submitted>
  <last_update_submitted_qc>November 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Max Institute of Neurosciences</investigator_affiliation>
    <investigator_full_name>Yashbir Dewan</investigator_full_name>
    <investigator_title>Consultant Neurosurgeon</investigator_title>
  </responsible_party>
  <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/NCT01730183
org study id: TPSC/POC/BMSC/SCI
nct id: NCT01730183
nct alias: NCT01490242
lead sponsor: 
has dmc: No
This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate
      the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal
      cord injury patients.
Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that
      usually leads to severe and permanent paralysis and the projected data related to the burden
      of spinal cord injuries across the globe is quite alarming. Pharmacological and
      rehabilitation therapies to SCI have got limited effect. There is definitely an urgent need
      for finding different methods of treatment for these patients who cannot undergo established
      modalities of treatment or these have been tried unsuccessfully. Another promising
      therapeutic approach for SCI is "Stem cell transplantation". Bone marrow derived stem cells
      have been shown to promote anatomical and functional recovery in animal models of SCI by
      promoting tissue sparing, axonal regeneration, and remyelination. In our present study, we
      want to evaluate the safety and efficacy of autologous bone marrow derived stem cells
      surgically transplanted intrathecally into patients with spinal cord injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events as a measure of safety and tolerability.
time frame: 18 months
description: The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.
measure: Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.
time frame: 18 months
description: Improvement in the functional Independence as measured by Spinal Cord Independence Measure (SCIM III). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Improvement in the pain sensation score as measured by Bryce/Ragnarsson SCI pain taxonomy (BR-SCI-PT). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Significant Changes in the muscle tone as indicated by Modified Ashworth Scale (MAS). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Improvement in the Clinical Outcome Variable Scale (COVS) score. [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
arm group label: Bone marrow derived stem cells
arm group type: Experimental
description: Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.
intervention type: Other
intervention name: Bone marrow derived stem cells
description: Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.
arm group label: Bone marrow derived stem cells
other name: Bone Marrow derived Mononucleated stem cell (BMMNCs)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Yashbir Dewan, MS, MCh
role: Principal Investigator
affiliation: Max Healthcare
last name: Yashbir Dewan, MS, MCh
role: Study Chair
affiliation: Max Helathcare
last name: Yashbir Dewan, MS, MCh
phone: +91-8800255922
email: dr.ydewanneuro@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: India
citation: Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.
PMID: 19364066
responsible party type: Principal Investigator
investigator affiliation: Max Institute of Neurosciences
investigator full name: Yashbir Dewan
investigator title: Consultant Neurosurgeon
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries