<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/NCT02260713</url>
  </required_header>
  <id_info>
    <org_study_id>ISIC-BMC</org_study_id>
    <nct_id>NCT02260713</nct_id>
  </id_info>
  <brief_title>Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study.</brief_title>
  <official_title>Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indian Spinal Injuries Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indian Council of Medical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indian Spinal Injuries Centre</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>
      Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and&#xD;
      feasibility of autologous bone marrow cell transplantation in case of acute complete spinal&#xD;
      cord injury by each of the following techniques and a corresponding number of controlled&#xD;
      subjects:&#xD;
&#xD;
        -  Directly into the injured site with a syringe after exposing the spinal cord.&#xD;
&#xD;
        -  By Intrathecal injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention : Autologous bone marrow cell: Transplantation of the autologous bone marrow&#xD;
      cell transplantation through one of the below mentioned techniques: 1. Directly into the&#xD;
      injured spinal cord site with a syringe after exposing the spinal cord. 2. By Intrathecal&#xD;
      injection. Number of cells Injected: 200 million cells in 1.8 ml of autologous plasma. In&#xD;
      case of Direct delivery, the cells were delivered in one sitting at six sites ( 2 above the&#xD;
      lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of&#xD;
      Intrathecal injection, the cells were delivered as a single injection of 1.8ml via lumbar&#xD;
      puncture. Frequency of Injection: Single Total duration of Therapy: The procedure of Bone&#xD;
      marrow harvesting, enrichment and transplantation was completed in a single setting of&#xD;
      approximately 2-3 hours. The transplantation procedure in case of Direct delivery took 2 mins&#xD;
      per injection site that is approximately 12 mins and in case of lumbar puncture the&#xD;
      transplantation procedure took approximately 2 mins.&#xD;
&#xD;
      Comparator Agent:Control: control subjects with acute complete spinal cord injury who would&#xD;
      not receive any bone marrow transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2011</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Examine for improvement in the ASIA classification.</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Blinded assessors will examine for improvement in the ASIA classification of at least one grade by 12 months or change from baseline of 10 points or more in total motor score, with consideration of their distribution along the neuraxis, from the ASIA Impairment Scale (AIS) manual motor test by 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement by at least 1 point on the WISCI scale</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in ASIA sensory examination</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in SCIM score</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological evaluation</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in EMG</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in SSEP</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in MEP</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Significant change in any of the variables included in urodynamic assessment</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in any of the variables included in ISCIS</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Acute Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transplantation via intrathecal route</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transplantation via intralesional route</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site .</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>autologous bone marrow cell</intervention_name>
    <description>Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture.</description>
    <arm_group_label>Transplantation via intralesional route</arm_group_label>
    <arm_group_label>Transplantation via intrathecal route</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute spinal cord injury between 10 days and 14 days post injury.&#xD;
&#xD;
          2. The subject must have a traumatic spinal cord injury between the spinal segmental&#xD;
             levels T1 and T12 (Neurological Level).&#xD;
&#xD;
          3. Must have a complete injury (ASIA-A).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject whose medical condition requires mechanical ventilation.&#xD;
&#xD;
          2. Subjects with neurological level of injury above T1 and below T12.&#xD;
&#xD;
          3. Subjects more than 14 days and less than 10 days post-injury.&#xD;
&#xD;
          4. Lower motor neuron injury.&#xD;
&#xD;
          5. Subjects with pathological fracture.&#xD;
&#xD;
          6. Spinal Injuries in subjects with Ankylosing Spondylitis.&#xD;
&#xD;
          7. Subjects with extremes of age: less than 18 years or more than 50 years.&#xD;
&#xD;
          8. Subjects with pre-existing severe medical disease which would affect the outcome like&#xD;
             severe diabetes, rheumatoid arthritis.&#xD;
&#xD;
          9. Subjects with Psychological disorders.&#xD;
&#xD;
         10. Female subjects with pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Harvinder S Chhabra, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indian Spinal Injuries Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indian Spinal Injury Center</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <results_reference>
    <citation>Chhabra HS, Sarda K, Arora M, Sharawat R, Singh V, Nanda A, Sangodimath GM, Tandon V. Autologous bone marrow cell transplantation in acute spinal cord injury--an Indian pilot study. Spinal Cord. 2016 Jan;54(1):57-64. doi: 10.1038/sc.2015.134. Epub 2015 Aug 18.</citation>
    <PMID>26282492</PMID>
  </results_reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>March 9, 2018</last_update_submitted>
  <last_update_submitted_qc>March 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <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/NCT02260713
org study id: ISIC-BMC
nct id: NCT02260713
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and
      feasibility of autologous bone marrow cell transplantation in case of acute complete spinal
      cord injury by each of the following techniques and a corresponding number of controlled
      subjects:

        -  Directly into the injured site with a syringe after exposing the spinal cord.

        -  By Intrathecal injection.
Intervention : Autologous bone marrow cell: Transplantation of the autologous bone marrow
      cell transplantation through one of the below mentioned techniques: 1. Directly into the
      injured spinal cord site with a syringe after exposing the spinal cord. 2. By Intrathecal
      injection. Number of cells Injected: 200 million cells in 1.8 ml of autologous plasma. In
      case of Direct delivery, the cells were delivered in one sitting at six sites ( 2 above the
      lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of
      Intrathecal injection, the cells were delivered as a single injection of 1.8ml via lumbar
      puncture. Frequency of Injection: Single Total duration of Therapy: The procedure of Bone
      marrow harvesting, enrichment and transplantation was completed in a single setting of
      approximately 2-3 hours. The transplantation procedure in case of Direct delivery took 2 mins
      per injection site that is approximately 12 mins and in case of lumbar puncture the
      transplantation procedure took approximately 2 mins.

      Comparator Agent:Control: control subjects with acute complete spinal cord injury who would
      not receive any bone marrow transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Examine for improvement in the ASIA classification.
time frame: up to 5 years
description: Blinded assessors will examine for improvement in the ASIA classification of at least one grade by 12 months or change from baseline of 10 points or more in total motor score, with consideration of their distribution along the neuraxis, from the ASIA Impairment Scale (AIS) manual motor test by 12 months.
measure: Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury
time frame: up to 5 years
measure: Improvement by at least 1 point on the WISCI scale
time frame: up to 5 years
measure: Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale
time frame: up to 5 years
measure: Improvement in ASIA sensory examination
time frame: up to 5 years
measure: Improvements in SCIM score
time frame: up to 5 years
measure: Psychological evaluation
time frame: up to 5 years
measure: Improvements in EMG
time frame: up to 5 years
measure: Improvements in SSEP
time frame: up to 5 years
measure: Improvements in MEP
time frame: up to 5 years
measure: Significant change in any of the variables included in urodynamic assessment
time frame: up to 5 years
measure: Improvements in any of the variables included in ISCIS
time frame: up to 5 years
arm group label: Control
arm group type: No Intervention
description: control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.
arm group label: Transplantation via intrathecal route
arm group type: Experimental
description: Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture
arm group label: Transplantation via intralesional route
arm group type: Experimental
description: Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site .
intervention type: Biological
intervention name: autologous bone marrow cell
description: Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture.
arm group label: Transplantation via intralesional route
arm group label: Transplantation via intrathecal route
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Dr Harvinder S Chhabra, MS
role: Principal Investigator
affiliation: Indian Spinal Injuries Centre
facility: 
country: India
citation: Chhabra HS, Sarda K, Arora M, Sharawat R, Singh V, Nanda A, Sangodimath GM, Tandon V. Autologous bone marrow cell transplantation in acute spinal cord injury--an Indian pilot study. Spinal Cord. 2016 Jan;54(1):57-64. doi: 10.1038/sc.2015.134. Epub 2015 Aug 18.
PMID: 26282492
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No