Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
Phase 1/Phase 2
10 Years
36 Years
10 Years
36 Years
Not Enrolling
Both
Chronic Spinal Cord Injury
Both
Chronic Spinal Cord Injury
Trial Information
Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
Inclusion Criteria:
- Traumatic spinal cord injury
- No concomitant systemic disease
- No progress on physiotherapy for at least 6 months
- Duration of injury from 10 months to 3 years
Exclusion Criteria:
- Non-traumatic spinal cord injury whether transverse myelitis or demyelination
- Concomitant systemic disease
- Progress can be observed on physiotherapy
- Acute injury or duration of injury less than 10 months
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.
Outcome Time Frame:
18 months
Safety Issue:
Yes
Authority:
Egypt: Ministry of Health and Population
Study ID:
EGY-SCI-1
NCT ID:
NCT00816803
Start Date:
May 2005
Completion Date:
December 2008
Related Keywords:
- Chronic Spinal Cord Injury
- Spinal cord injury
- Spinal Cord Injuries
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