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Sponsors and Collaborators: |
Cairo University Alazhar University, Egypt Medical Military Academy, Egypt Alexandria University, Egypt |
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Information provided by: | Cairo University |
ClinicalTrials.gov Identifier: | NCT00816803 |
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.
Condition | Intervention | Phase |
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Chronic Spinal Cord Injury |
Procedure: Autologous bone marrow transplant Procedure: Physical therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients |
Enrollment: | 80 |
Study Start Date: | May 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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BM transplant with physiotherapy: Experimental
Autologous BM transplant
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Procedure: Autologous bone marrow transplant Procedure: Physical therapy |
Physiotherapy only: Active Comparator
conventional physical therapy for chronic spinal cord injury.
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Procedure: Physical therapy |
Ages Eligible for Study: | 10 Years to 36 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cairo University, and the Cancer Institute of New Jersey, UMDNJ/RWJMS ( Hatem E. Sabaawy, M, PhD, Assistant Professor of Medicine ) |
Study ID Numbers: | EGY-SCI-1 |
Study First Received: | December 31, 2008 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00816803 |
Health Authority: | Egypt: Ministry of Health and Population |
Spinal cord injury |
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Nervous System Diseases |