학술논문
Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study.
Document Type
article
Author
Oscar Fernández; Guillermo Izquierdo; Victoria Fernández; Laura Leyva; Virginia Reyes; Miguel Guerrero; Antonio León; Carlos Arnaiz; Guillermo Navarro; Maria Dolores Páramo; Antonio De la Cuesta; Bernat Soria; Abdelkrim Hmadcha; David Pozo; Rafael Fernandez-Montesinos; Maria Leal; Itziar Ochotorena; Patricia Gálvez; Maria Angeles Geniz; Francisco Javier Barón; Rosario Mata; Cristina Medina; Carlos Caparrós-Escudero; Ana Cardesa; Natividad Cuende; Research Group Study EudraCT 2008-004015
Source
PLoS ONE, Vol 13, Iss 5, p e0195891 (2018)
Subject
Language
English
ISSN
1932-6203
Abstract
Currently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option and can be readily obtained using minimally invasive procedures.In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded.Thirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product. Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy.Infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique.