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Trial record 57 of 7623 for:    stem cells

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

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

Tracking Information
First Submitted Date  ICMJE November 15, 2012
First Posted Date  ICMJE November 21, 2012
Last Update Posted Date November 21, 2012
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE 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  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 15, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01730183
Other Study ID Numbers  ICMJE TPSC/POC/BMSC/SCI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yashbir Dewan, Max Institute of Neurosciences
Study Sponsor  ICMJE Max Institute of Neurosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

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