Safety and Feasibility of Autologous Mesenchymal Stem Cell Transplantation in Chronic Stroke in Indian patients. A four-year follow up.

Introduction: Stem cell (SC) therapy has been envisioned as a therapeutic vehicle to promote recovery in resistant neurological diseases. Knowing the logistics and paradigms in recovery processes after Stroke, clinicians have pioneered the transplantation therapy. This study presents four-year follow up of our previous trial transplanting bone-marrow-derived animal-free culture expanded intravenous mesenchymal stem cells (MSCs) in chronic stroke which was published in 2010. Methods: We performed an open-label, pilot trial on 12 patients with chronic stroke. Patients were allocated to two groups, those who received intravenous autologous ex vivo cultured mesenchymal stem cells (MSC group) or those who did not (control group), all followed for four years from the day of cell transplantation. Results: The reports have been optimistic regarding safety as we did not find any cell related side effects / mortality till 208th week. We observed that modified Barthel Index showed statistical significant improvement at 156 and 208 weeks of transplantation (95 % CI : -10.27 to 0.07; p =0.041) follow up in the MSC group as compared to controls. The 2nd and 3rd quartile for mBI in MSC group was 89 & 90 respectively suggesting good performance of patients in the stem cell group. The impairment scales i.e., Fugl Meyer, Ashworth tone scale, strength of hand muscles (MRC) did not show any significant improvement at 208th week which is similar to our previous published report. Conclusion: This follow up study primarily indicates safety, tolerance and applicability of autologous mesenchymal stem cells in Stroke. MSCs may act as "chaperones" or work through paracrine mechanisms leading to functional recovery post stroke.