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- Title
Stem Cell Therapy for Multiple Sclerosise.
- Authors
Nabavi, S. M.
- Abstract
Objective: Although DMDs reduce the rate of relapses of MS, there is no effective means to stop the progression of disability or induce rebuilding of the destroyed myelin and axons. Adult bone marrow derived stromal cells (MSC) were shown to induce immunomodulatory and neuroregenerative effects and to induce neuroprotection in the animal model of EAE In VIvo.We have designed a Randomized clinical trial, semi cross over,Phase I/II study to evaluate the safety and efficacy of intravenous injection of autologous bone marrow derived mesenchymal stem cell in patients with multiple sclerosis. Materials and Methods: 30 patients (18-55 years, 3<EDSS<6.5) with RRMS , SPMS with relapses or PPMS with inflammatory characters who were resistant to the approved DMDs,i.e with specific eligibility criteria to define resistance randomly recruited .Bone marrow aspiration are done for all patients. Patients are randomly divided in 2 groups: cell recipient (early treatment group) and control (delayed treatment group). Then mesenchymal stem cells are transplanted by intravenous injection to the patients in case group and the cells of patients in control group are frozen and inject after 6 months. Patients will be followed by Evaluation of immediate and late clinical and laboratory side effects, Relapses, EDSS progression , RAO Test , MRI ,CSF markers and quality of life questionnaire at the Baseline and after 1th, 3th, 6th and 12th months of transplantation. Results: Up to June 2013, 21patients were injected and 15 out of them had their second injection.After 6 months follow up, there were not any clinical or laboratory adverse events.No immideate clinical reactions within the first 6 hours and any clinical and laboratory adverse events between 48 h and 6 months follow up were seen. Some patients got better with EDSS improvement and without any relapse but we don't have any judgment because it has not finished yet. 2 patients had relapses and in only one patient 3 severe disabling relapses occurred within 5 months. we did not detect any new GAD+ lesions in the patients MRI. Conclusion: The Intravenous transplantation of autologous MSC is safe without any adverse effect. Efficacy should be proved at the end of the study
- Publication
Cell Journal (Yakhteh), 2013, Vol 15, Issue Sup 1, p25
- ISSN
2228-5806
- Publication type
Academic Journal