A double-blind placebo-controlled clinical evaluation of MultiStem for the treatment of ischemic stroke

David C. Hess, Cathy A. Sila, Anthony J. Furlan, Larry R. Wechsler, Jeffrey A. Switzer, Robert W. Mays

Research output: Contribution to journalArticle

62 Scopus citations

Abstract

Background: There is growing interest in neurorestorative and reparative therapies after acute stroke. MultiStem® is an allogeneic cell therapy treatment comprising a population of multipotent adherent bone marrow cells that has shown safety in clinical trials of myocardial infarction and graft vs. host disease, as well as preclinical evidence of activity in stroke and other neurological damage models. MultiStem is now being evaluated in a clinical trial in patients that have suffered an ischemic stroke, in which the product is administered intravenously 24-36h after the ischemic event. Methods: The Phase 2 randomized, double-blind, placebo-controlled, multicenter dose-escalation trial will consist of three treatment cohorts, including a placebo group, and two treatment groups involving dose tiers of either 400 million or 1200 million cells per patient. Patients will be treated at 24-36h after stroke. The two primary objectives are to determine the highest well-tolerated and safe single dose of MultiStem up to a maximum of 1200 million total cells in subjects with ischemic stroke and to determine the efficacy of MultiStem on functional outcome in subjects with stroke as measured by the modified Rankin Scale at 90 days. Patients will also be evaluated using the National Institutes of Health Stroke Scale and Barthel Index. The study will explore other aspects including, uniquely, the measurement of spleen size after stroke by magnetic resonance imaging or computed tomography imaging. Conclusions and future direction: If MultiStem is safe and there is a signal of efficacy, a late stage phase IIb-III trial is planned.

Original languageEnglish (US)
Pages (from-to)381-386
Number of pages6
JournalInternational Journal of Stroke
Volume9
Issue number3
DOIs
StatePublished - Apr 2014

Keywords

  • Clinical trial
  • Ischemic stroke
  • Multipotent stem cell
  • Spleen
  • Stem cell

ASJC Scopus subject areas

  • Neurology

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