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| Sponsor: | The Cleveland Clinic |
|---|---|
| Collaborator: |
University Hospital Case Medical Center |
| Information provided by: | The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT00813969 |
Purpose
The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal stem cell transplantation, involving approximately 24 participants with relapsing forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/ progressive relapsing MS) and evidence of involvement of the anterior afferent visual system.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing-Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis |
Biological: Autologous mesenchymal stem cell transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase I Study to Assess the Feasibility, Safety, and Tolerability of Autologous Mesenchymal Stem Cell Transplantation in Patients With Relapsing Forms of Multiple Sclerosis |
| Estimated Enrollment: | 24 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Total lymphoid irradiation. Cladribine. T-cell or T-cell receptor vaccination. Campath-1h (alemtuzumab). Rituxan (rituximab).
Tysabri (natalizumab). Zenapax (daclizumab). Cytoxan (cyclophosphamide). Novantrone (mitoxantrone). Cyclosporine. CellCept (mycophenolate mofetil). Imuran (azathioprine). Rheumatrex (methotrexate). IV gamma globulin. Plasma exchange.
Systemic corticosteroids with daily dose equivalent to Prednisone 60 mg or greater.
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Mellen Center | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Jeffrey A Cohen, M.D. | Cleveland Clinic |
More Information
| Responsible Party: | Cleveland Clinic, Mellen Center ( Jeffrey Alan Cohen, M.D. ) |
| Study ID Numbers: | MS-MSC-001 |
| Study First Received: | December 22, 2008 |
| Last Updated: | April 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00813969 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Mesenchymal Stem Cell MSC Autologous Multiple Sclerosis |
|
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases Nervous System Diseases |
Demyelinating Autoimmune Diseases, CNS Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System Multiple Sclerosis, Chronic Progressive |