RT Journal Article
T1 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.
A1 Fernandez, Oscar
A1 Izquierdo, Guillermo
A1 Fernandez, Victoria
A1 Leyva, Laura
A1 Reyes, Virginia
A1 Guerrero, Miguel
A1 Leon, Antonio
A1 Arnaiz, Carlos
A1 Navarro, Guillermo
A1 Paramo, Maria Dolores
A1 De-la-Cuesta, Antonio
A1 Soria, Bernat
A1 Hmadcha, Abdelkrim
A1 Pozo, David
A1 Fernandez-Montesinos, Rafael
A1 Leal, Maria
A1 Ochotorena, Itziar
A1 Galvez, Patricia
A1 Geniz, Maria Angeles
A1 Baron, Francisco Javier
A1 Mata, Rosario
A1 Medina, Cristina
A1 Caparros-Escudero, Carlos
A1 Cardesa, Ana
A1 Cuende, Natividad
K1 Adipose Tissue
K1 Adult
K1 Feasibility Studies
K1 Female
AB 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.
PB Public Library of Science
YR 2018
FD 2018-05-16
LK http://hdl.handle.net/10668/12476
UL http://hdl.handle.net/10668/12476
LA en
NO Fernández O, Izquierdo G, Fernández V, Leyva L, Reyes V, Guerrero M, et al.  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. PLoS One. 2018 May 16;13(5):e0195891
NO This work was supported by Instituto de Salud Carlos III, Ministry of Health – Spain – Grant number: EC08/00224-ISCIII; Grants from ISCIII cofunded by Fondos FEDER, FIS PI14/01015; RD/oo19/0028 and RD16/0011/0034 to B Soria and PI16/00259 to A Hmadcha
DS RISalud
RD Apr 17, 2025