Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis

Resumen:
At baseline 9 patients were randomized to receive MSCs (n¿=¿5) or placebo (n¿=¿4). One patient on placebo withdrew after having 3 relapses in the first 5 months. We did not identify any serious adverse events. At 6 months, patients treated with MSCs had a trend to lower mean cumulative number of GEL (3.1, 95% CI¿=¿1.1-8.8 vs 12.3, 95% CI¿=¿4.4-34.5, p¿=¿0.064), and at the end of study to reduced mean GEL (-2.8±5.9 vs 3±5.4, p¿=¿0.075). No significant treatment differences were detected in the secondary endpoints. We observed a non-significant decrease of the frequency of Th1 (CD4+ IFN-¿+) cells in blood of MSCs treated patients. CONCLUSION: Bone-marrow-MSCs are safe and may reduce inflammatory MRI parameters supporting their immunomodulatory properties. ClinicalTrials.gov NCT01228266.