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

• ClinicalTrials.gov Identifier: NCT01730183
• Recruitment Status: Unknown
• First Posted: November 21, 2012
• Last Update Posted: November 21, 2012
• Sponsor: Max Institute of Neurosciences
• Information provided by (Responsible Party): Yashbir Dewan, Max Institute of Neurosciences

Tracking Information

• First Submitted Date: November 15, 2012
• First Posted Date: November 21, 2012
• Last Update Posted Date: November 21, 2012
• Study Start Date: November 2012
• Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 15, 2012)

Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 18 months ]

The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 15, 2012)

Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function. [ Time Frame: 18 months ]

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury
• Official Title: To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Spinal Cord Injury

Intervention

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)

Study Arms

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 15, 2012): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2014
• Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01730183
• Other Study ID Numbers: TPSC/POC/BMSC/SCI
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yashbir Dewan, Max Institute of Neurosciences
• Study Sponsor: Max Institute of Neurosciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yashbir Dewan, MS, MCh; Max Healthcare
• Study Chair: Yashbir Dewan, MS, MCh; Max Helathcare

• PRS Account: Max Institute of Neurosciences
• Verification Date: November 2012