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
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Other: Bone marrow derived stem cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2014|
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)
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730183
|Contact: Yashbir Dewan, MS, MChfirstname.lastname@example.org|
|Max Super speciality Hospital||Recruiting|
|Dehradun, Uttrakhand, India, 248001|
|Contact +91-8800255922 email@example.com|
|Principal Investigator: Yashbir Dewan, MS, MCh|
|Principal Investigator:||Yashbir Dewan, MS, MCh||Max Healthcare|
|Study Chair:||Yashbir Dewan, MS, MCh||Max Helathcare|