Chronic Spinal Cord Injury
Conditions
Keywords
Spinal cord injury
Brief summary
This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.
Interventions
PROCEDUREAutologous bone marrow transplant
PROCEDUREPhysical therapy
Sponsors
Al-Azhar University
Medical Military Academy, Egypt
Alexandria University
Cairo University
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 36 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI. | 18 months |
Countries
Egypt
Outcome results
None listed