Are our expectations too high?
Rather than write a piece at the end, I have added to the abstract in Magenta
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. 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.PLoS One. 2018 May 16;13(5):e0195891.
BACKGROUND: 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 (“WHY?-WHAT IS THE EVIDENCE FOR A PROMISING OPTION? MOST STUDIES REPORT THAT MESENCHYMAL STEM CELLS INDUCE IMMUNE CHANGES, AND IMMUNE CHANGES HAVE LIMITED RAPID IMPACT ON PROGRESSIVE MS. SO WHY IS THIS PROMISING”), and can be readily obtained using minimally invasive procedures.(IMMUNE CHANGES CAN BE ACHIEVED WITH MANY CURRENT DMT)
PATIENTS AND METHODS: In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy (STEM CELLS WERE FROM FAT DEPOSITS) and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1×10 million cells/kg) or high-dose(4×10 million cells/kg) autologous AdMSC product and followed for 12 months (WE HAVE SEEN TIME AND TIME AGAIN THAT TRIALS OF 12 MONTHS ARE SIMPLY NOT LONG ENOUGH). 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.
RESULTS: 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 (THE CELLS HAD CHROMOSOMAL). 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. (NO SIDE EFFECT. IS THEIR EFFICACY?)
CONCLUSION: 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 (UGH!)