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Title: Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis.
Author: Llufriu Duran, Sara
Sepúlveda, María
Blanco, Yolanda
Marín, Pedro
Moreno, Beatriz
Berenguer, Joan
Gabilondo, Iñigo
Martínez-Heras, Eloy
Sola Valls, Nuria
Arnaiz Gargallo, Juan Alberto
Andreu, Enrique J.
Fernández, Begoña
Bullich Roig, Santiago
Sánchez Dalmau, Bernardo
Graus Ribas, Francesc
Villoslada, Pablo
Saiz Hinajeros, Albert
Keywords: Cèl·lules mare
Esclerosi múltiple
Ressonància magnètica
Cèl·lules T
Cèl·lules B
Assaigs clínics
Stem cells
Multiple sclerosis
Magnetic resonance
T cells
B cells
Clinical trials
Issue Date: 1-Dec-2014
Publisher: Public Library of Science (PLoS)
Abstract: OBJECTIVE: Uncontrolled studies of mesenchymal stem cells (MSCs) in multiple sclerosis suggested some beneficial effect. In this randomized, double-blind, placebo-controlled, crossover phase II study we investigated their safety and efficacy in relapsing-remitting multiple sclerosis patients. Efficacy was evaluated in terms of cumulative number of gadolinium-enhancing lesions (GEL) on magnetic resonance imaging (MRI) at 6 months and at the end of the study. METHODS: Patients unresponsive to conventional therapy, defined by at least 1 relapse and/or GEL on MRI scan in past 12 months, disease duration 2 to 10 years and Expanded Disability Status Scale (EDSS) 3.0-6.5 were randomized to receive IV 1-2×10(6) bone-marrow-derived-MSCs/Kg or placebo. After 6 months, the treatment was reversed and patients were followed-up for another 6 months. Secondary endpoints were clinical outcomes (relapses and disability by EDSS and MS Functional Composite), and several brain MRI and optical coherence tomography measures. Immunological tests were explored to assess the immunomodulatory effects. RESULTS: 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-γ+) cells in blood of MSCs treated patients. CONCLUSION: Bone-marrow-MSCs are safe and may reduce inflammatory MRI parameters supporting their immunomodulatory properties. NCT01228266.
Note: Reproducció del document publicat a:
It is part of: PLoS One, 2014, vol. 9, num. 12, p. e113936
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ISSN: 1932-6203
Appears in Collections:Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)
Articles publicats en revistes (Fonaments Clínics)

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