Bone marrow derived mesenchymal stromal cells (BM-MSCs) have emerged as a possible\nnew therapy for Multiple Sclerosis (MS), however studies regarding efficacy and in vivo immune\nresponse have been limited and inconclusive. We conducted a phase I clinical study assessing\nsafety and clinical and peripheral immune responses after MSC therapy in MS. Seven patients with\nprogressive MS were intravenously infused with a single dose of autologous MSC (1-2 * 106 MSCs/kg\nbody weight). The infusions were safe and well tolerated when given during clinical remission. Five\nout of seven patients completed the follow up of 48 weeks post-infusion. Brain magnetic resonance\nimaging (MRI) showed the absence of new T2 lesions at 12 weeks in 5/6 patients, while 3/5 had\naccumulated new T2 lesions at 48 weeks. Patient expanded disability status scales (EDSS) were stable\nin 6/6 at 12 weeks but declined in 3/5 patients at 48 weeks. Early changes of circulating microRNA\nlevels (2 h) and increased proportion of FOXP3+ Tregs were detected at 7 days post-infusion compared\nto baseline levels. In conclusion, MSC therapy was safe and well tolerated and is associated with\npossible transient beneficial clinical and peripheral immunotolerogenic effects.
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