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 Fernández Fernández, Óscar
A1 Izquierdo, Guillermo
A1 Fernández Sánchez, Victoria Eugenia
A1 Leyva-Fernández, Laura
A1 Reyes, Virginia
A1 Guerrero, Miguel
A1 León, Antonio
A1 Arnáiz, Carlos
A1 Navarro, Guillermo
A1 Páramo, Mª Dolores
A1 De la Cuesta, Antonio
A1 Soria, Bernat
A1 Hmadcha, Abdelkrim
A1 Pozo, David
A1 Fernández-Montesinos, Rafael
A1 Leal, María
A1 Ochotorena, Itziar
A1 Gálvez, Patricia
A1 Geniz, Mª Angeles
A1 Barón-López, Francisco Javier
A1 Mata, Rosario
A1 Medina, Cristina
A1 Caparrós-Escudero, Carlos
A1 Cardesa, Ana
A1 Cuende, Natividad
K1 Esclerosis múltiple - Tratamiento
K1 Ensayos clínicos
K1 Células madre
K1 Tejido adiposo
AB BackgroundCurrently available treatments for secondary progressive multiple sclerosis(SPMS) havelimited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs)represent a promising option and can be readily obtained using minimally invasiveprocedures.Patients and methodsIn this triple-blind, placebo-controlled study, cell samples were obtained from consentingpatients by lipectomy and subsequently expanded. Patients were randomized to a singleinfusion of placebo, low-dose(1x10^6 cells/kg) or high-dose(4x10^6 cells/kg) autologousAdMSC product and followed for 12 months. Safety was monitored recording adverseevents, laboratory parameters, vital signs and spirometry. Expanded disability status score(EDSS), magnetic-resonance-imaging, and other measures of possible treatment effectswere also recorded.ResultsThirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirtywere infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were notinfused because of karyotype abnormalities in the cell product. Only one serious adverseevent was observed in the treatment arms (urinary infection, considered not related to studytreatment). No other safety parameters showed changes. Measures of treatment effectshowed an inconclusive trend of efficacy.ConclusionInfusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studiesand probably treatment at earlier phases would be needed to investigate the potential therapeuticbenefit of this technique.
PB Public Library of Science
YR 2018
FD 2018-05-16
LK https://hdl.handle.net/10630/40849
UL https://hdl.handle.net/10630/40849
LA eng
NO Fernández O, Izquierdo G, Fernández V, Leyva L, Reyes V, Guerrero M, León A, Arnaiz C, Navarro G, Páramo MD, Cuesta A, Soria B, Hmadcha A, Pozo D, Fernandez-Montesinos R, Leal M, Ochotorena I, Gálvez P, Geniz MA, Barón FJ, Mata R, Medina C, Caparrós-Escudero C, Cardesa A, Cuende N; Research Group Study EudraCT 2008-004015-35. 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. doi: 10.1371/journal.pone.0195891. PMID: 29768414; PMCID: PMC5955528.
NO Andalusian Initiative for Advanced Therapies, supported by the Andalusian Health and Progress Foundation.
NO Instituto de Salud Carlos III, Ministry of Health,Spain. Grant number: EC08/00224-ISCIII to O. Fernández and G Izquierdo.; Grants from ISCIII FIS PI14/01015; RD/ 0019/0028 and RD16/0011/0034 to B Soria and PI16/00259 to A Hmadcha. Research Group Study EudraCT 2008-004015-35
DS RIUMA. Repositorio Institucional de la Universidad de Málaga
RD 21 ene 2026