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oai:repisalud.isciii.es:20.500.12105/175992024-09-21T18:12:52Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16927

00925njm 22002777a 4500 dc Fernández, Oscar author Izquierdo, Guillermo author Fernández, Victoria author Leyva, Laura author Reyes, Virginia author Guerrero, Miguel author León, Antonio author Arnaiz, Carlos author Navarro, Guillermo author Páramo, Maria Dolores author Cuesta, Antonio De la author Soria, Bernat author Hmadcha, Abdelkrim author Pozo, David author Fernandez-Montesinos, Rafael author Leal, Maria author Ochotorena, Itziar author Gálvez, Patricia author Geniz, Maria Angeles author Barón, Francisco Javier author Mata, Rosario author Medina, Cristina author Caparrós-Escudero, Carlos author Cardesa, Ana author Cuende, Natividad author Research Group Study EudraCT 2008-004015-35 author 2018-05-16 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. 10.1371/journal.pone.0195891 1932-6203 PloS one http://hdl.handle.net/10668/12476 29768414 http://hdl.handle.net/20.500.12105/17599 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.