Journal article
Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial
A Jaillard, M Hommel, A Moisan, TA Zeffiro, IM Favre-Wiki, M Barbieux-Guillot, W Vadot, S Marcel, L Lamalle, S Grand, O Detante, S Achard, P Antoine, EL Barbier, CE Bulabois, L Carey, A Chrispin, M Cucherat, P Davoine, F de Fraipont Show all
Translational Stroke Research | SPRINGER | Published : 2020
Abstract
While preclinical stroke studies have shown that mesenchymal stem cells (MSCs) promote recovery, few randomized controlled trials (RCT) have assessed cell therapy in humans. In this RCT, we assessed the safety, feasibility, and efficacy of intravenous autologous bone marrow-derived MSCs in subacute stroke. ISIS-HERMES was a single-center, open-label RCT, with a 2-year follow-up. We enrolled patients aged 18–70 years less than 2 weeks following moderate-severe ischemic carotid stroke. Patients were randomized 2:1 to receive intravenous MSCs or not. Primary outcomes assessed feasibility and safety. Secondary outcomes assessed global and motor recovery. Passive wrist movement functional MRI (fM..
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Awarded by European Commission
Funding Acknowledgements
This trial was funded by an academic grant from the French Health Ministry: PHRCI Grant numbers: ISIS-2007PHR04 and HERMES-2007-A00853-50. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. MRI data acquisition was performed at the IRMaGe MRI platform, which gratefully acknowledge financial support from France Life Imaging network through the grant "ANR-11-INBS-0006." Data monitoring was performed by the Clinical Investigation Center (CIC) INSERM UMS 002 CHU Grenoble Alpes. Data analysis was partly supported by RESSTORE project (www.resstore.eu) funded by the European Commission under the H2020 program (Grant Number 681044).