• J Stroke Cerebrovasc Dis · Nov 2014

    Randomized Controlled Trial

    Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem cells from adipose tissue: a safety assessment: a phase II randomized, double-blind, placebo-controlled, single-center, pilot clinical trial.

    • Exuperio Díez-Tejedor, María Gutiérrez-Fernández, Patricia Martínez-Sánchez, Berta Rodríguez-Frutos, Gerardo Ruiz-Ares, Manuel Lara Lara, and Blanca Fuentes Gimeno.
    • Stroke Center, Department of Neurology, La Paz University Hospital, IdiPAZ Health Research Institute, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: exuperio.diez@salud.madrid.org.
    • J Stroke Cerebrovasc Dis. 2014 Nov 1; 23 (10): 2694-700.

    BackgroundFew studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke. Intravenous administration of allogeneic mesenchymal stem cells (MSCs) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair, consequently supporting better functional recovery. We aim to assess the safety and efficacy of MSC administration and evaluate its potential as a treatment for cerebral protection and repair.MaterialsA Phase IIa, prospective, randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. Twenty patients presenting acute ischemic stroke will be randomized in a 1:1 proportion to treatment with allogeneic MSCs from adipose tissue or to placebo (or vehicle) administered as a single intravenous dose within the first 2 weeks after the onset of stroke symptoms. The patients will be followed up for 2 years. Primary outcomes for safety analysis: adverse events (AEs) and serious AEs; neurologic and systemic complications, and tumor development. Secondary outcomes for efficacy analysis: modified Rankin Scale; NIHSS; infarct size; and biochemical markers of brain repair (vascular endothelial growth factor, brain-derived neurotrophic factor, and matrix metalloproteinases 9).Results And ConclusionsTo our knowledge, this is the first, phase II, pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic MSCs from adipose tissue within the first 2 weeks of stroke. In addition, its results will help us define the best criteria for a future phase III study.Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

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