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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 22, 2008 | ||||
| Last Updated Date | April 15, 2009 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To evaluate infusion-related safety and tolerability of autologous MSC transplantation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00813969 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment, Safety Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Biological: Autologous mesenchymal stem cell transplantation | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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.
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00813969 | ||||
| Responsible Party | Jeffrey Alan Cohen, M.D., Cleveland Clinic, Mellen Center | ||||
| Study ID Numbers ICMJE | MS-MSC-001 | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | University Hospital Case Medical Center | ||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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