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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.
Max Super speciality Hospital
Dehradun, Uttrakhand, India
RECRUITINGNumber of participants with adverse events as a measure of safety and tolerability.
The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.
Time frame: 18 months
Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.
* 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. \[ Time Frame: Baseline and 18 months \] \[ Designated as safety issue: No \]
Time frame: 18 months
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