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To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (ABSCI)

This study is currently recruiting participants.
Verified November 2012 by Max Institute of Neurosciences
Sponsor:
Information provided by (Responsible Party):
Yashbir Dewan, Max Institute of Neurosciences
ClinicalTrials.gov Identifier:
NCT01730183
First received: November 15, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
 Other: Bone marrow derived stem cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Max Institute of Neurosciences:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.


Secondary Outcome Measures:
  • Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    • 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 ]


Estimated Enrollment: 15
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone marrow derived stem cells
Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.
 Other: Bone marrow derived stem cells
Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.
Other Name: Bone Marrow derived Mononucleated stem cell (BMMNCs)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Traumatic injury of the spinal cord (below C5 level) occurring within 6 months to 8 years prior to treatment, resulting in a sustained and complete / Partial loss of sensory and motor function below the injury (ASIA Category A, B and C ).
  2. Confirmation spinal cord injury level (Patients with complete or partial transection/damage by MRI).
  3. Those provide fully informed consent.
  4. The level of spinal cord injury must be below C4.

Exclusion Criteria:

  1. Spinal vertebral instability.
  2. Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)
  3. ASIA Impairment Scale category other than D & E.
  4. Lactating and pregnant women.
  5. Syringomyelia is also an exclusion criterion but an exemption can be made for a patient with a stable syrinx.
  6. Platelet count greater than 100 thousand/µl at screening.
  7. Hematocrit less than 30% prior to bone marrow aspiration.
  8. Patients with major and current psychiatric illness.
  9. Significant traumatic brain injury associated with the spinal cord injury.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730183

Contacts
Contact: Yashbir Dewan, MS, MCh +91-8800255922 dr.ydewanneuro@gmail.com

Locations
India
Max Super speciality Hospital Recruiting
Dehradun, Uttrakhand, India, 248001
Contact     +91-8800255922     dr.ydewanneuro@gmail.com    
Principal Investigator: Yashbir Dewan, MS, MCh            
Sponsors and Collaborators
Max Institute of Neurosciences
Investigators
Principal Investigator: Yashbir Dewan, MS, MCh Max Healthcare
Study Chair: Yashbir Dewan, MS, MCh Max Helathcare
  More Information

Publications:

Responsible Party: Yashbir Dewan, Consultant Neurosurgeon, Max Institute of Neurosciences
ClinicalTrials.gov Identifier: NCT01730183     History of Changes
Obsolete Identifiers: NCT01490242
Other Study ID Numbers: TPSC/POC/BMSC/SCI
Study First Received: November 15, 2012
Last Updated: November 15, 2012
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013