Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
The Cleveland Clinic University Hospital Case Medical Center |
---|---|
Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00813969 |
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: | January 2009 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
United States, Ohio | |
Cleveland Clinic Mellen Center | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Jeffrey A Cohen, M.D. | Cleveland Clinic |
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: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00813969 |
Health Authority: | United States: Food and Drug Administration |
Mesenchymal Stem Cell MSC Autologous Multiple Sclerosis |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Neoplasm Metastasis Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System Multiple Sclerosis, Chronic Progressive |
Pathologic Processes Immune System Diseases Nervous System Diseases |