Detalle Publicación


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

Autores: Llufriu, Sara ; Sepúlveda, María ; Blanco, Yolanda ; Marín, Pedro ; Moreno, Beatriz ; Berenguer, Joan ; Gabilondo, Iñigo ; Martínez-Heras, Eloy ; Sola-Valls, Nuria; Arnaiz, Joan-Albert ; Andreu Oltra, Enrique José; Fernández, Begoña ; Bullich, Santi ; Sánchez-Dalmau, Bernardo ; Graus, Francesc ; Villoslada Díaz, Pablo; Saiz, Albert
Título de la revista: PLOS ONE
ISSN: 1932-6203
Volumen: 9
Número: 12
Páginas: e113936
Fecha de publicación: 2014
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. NCT01228266.