Mesenchymal Stem Cell Transplantation in MS

Phase 2 Terminated 9 enrolled Albert Saiz Instituto de Salud Carlos III · collab

RandomizedCrossoverDouble-blindTreatment

Summary

The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis

Timeline

Start: 2010-12
Primary completion: 2013-06
Completion: 2013-12

Outcome

Missed primary endpoint

Stopped (Enrollment): “Ended the recruitment in June 2012 for low enrollement accrual”

paper 3.1, 95% CI = 1.1-8.8 vs 12.3, 95% CI = 4.4-34.5, p = 0.064 PMID 25436769 ↗

paper -2.8±5.9 vs 3±5.4, p = 0.075 PMID 25436769 ↗

Publications

Llufriu S, Sepulveda M, Blanco Y, Marin P, Moreno B, Berenguer J, Gabilondo I, Martinez-Heras E, Sola-Valls N, Arnaiz JA, Andreu EJ, Fernandez B, Bullich S, Sanchez-Dalmau B, Graus F, Villoslada P, Saiz A. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014 Dec 1;9(12):e113936. doi: 10.1371/journal.pone.0113936. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mesenchymal stem cells	Cell therapy	2e+06 cells/kg	Intravenous