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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

November 15, 2012
November 15, 2012
November 2012
November 2014   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury
To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)

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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)
Experimental: Bone marrow derived stem cells
Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.
Intervention: Other: Bone marrow derived stem cells
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
November 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Yashbir Dewan, MS, MCh +91-8800255922 dr.ydewanneuro@gmail.com
India
 
NCT01730183
TPSC/POC/BMSC/SCI
No
Yashbir Dewan, Max Institute of Neurosciences
Max Institute of Neurosciences
Not Provided
Principal Investigator: Yashbir Dewan, MS, MCh Max Healthcare
Study Chair: Yashbir Dewan, MS, MCh Max Helathcare
Max Institute of Neurosciences
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP