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

• DOI: 10.1371/journal.pone.0195891
• Publication Date: 2018-05-16T13:43:25Z
• Authors: 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-...; Maria Leal; Itziar Ochotorena; Patricia Gálvez; Maria Angeles Geniz; Francisco Javier ...; Rosario Mata; Cristina Medina; Carlos Caparrós-E...; Ana Cardesa; Natividad Cuende
• Keywords: Adult; Male; Células madre; Science; Esclerosis múltiple crónica progresiva; Mesenchymal Stem Cell Transplantation; 03 medical and health sciences; Humans; 0303 health sciences; Infecciones; Q; R; Mesenchymal Stem Cells; Signos vitales; Magnetismo; Middle Aged; Multiple Sclerosis, Chronic Progressive; 3. Good health; Treatment Outcome; Adipose Tissue; Espirometría; Medicine; Feasibility Studies; Female; Research Article

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 from consenting patients by lipectomy subsequently expanded. Patients randomized to single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product followed 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, other measures possible treatment effects also recorded.Thirty-four underwent AdMSCs collection, thirty infused (11 10 low-dose 9 high-dose); 4 not because karyotype abnormalities in the product. Only one serious event observed arms (urinary infection, considered related study treatment). No parameters showed changes. Measures effect an inconclusive trend efficacy.Infusion is safe feasible with SPMS. Larger studies probably at earlier phases would needed investigate potential therapeutic benefit technique.