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| Sponsor: | Jeff Cohen |
|---|---|
| Collaborator: |
University Hospital Case Medical Center |
| Information provided by (Responsible Party): | Jeff Cohen, Cleveland Clinic Foundation |
| 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 ambulatory 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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | March 2011 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Autologous MSC transplantation |
Biological: Autologous mesenchymal stem cell transplantation
A single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion
|
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). Gilenya (Fingolimod/FTY720). 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 | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Cynthia S Schwanger, RN,BSN,MSCN 216-445-5788 schwanc@ccf.org | |
| Contact: Sarah M Planchon Pope, Ph.D., CCRP 216-636-1232 planchs@ccf.org | |
| Principal Investigator: Jeffrey A Cohen, M.D. | |
| Principal Investigator: | Jeffrey A Cohen, M.D. | The Cleveland Clinic |
More Information
| Responsible Party: | Jeff Cohen, Director of Experimental Therapeutics, Mellen Center for MS Treatment and Research, Cleveland Clinic Foundation |
| ClinicalTrials.gov Identifier: | NCT00813969 History of Changes |
| Other Study ID Numbers: | MS-MSC-001 |
| Study First Received: | December 22, 2008 |
| Last Updated: | September 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Mesenchymal Stem Cell MSC Autologous Multiple Sclerosis |
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |