title: A double-blind placebo-controlled clinical evaluation of MultiStem for the treatment of ischemic stroke.
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 24-36 h 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 24-36 h 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.
  If MultiStem is safe and there is a signal of efficacy, a late stage phase IIb-III trial is planned.
authors.affiliation: Department of Neurology, Georgia Health Sciences University, Augusta, GA, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Hess
authors.forename: Cathy A
authors.initials: CA
authors.lastname: Sila
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Furlan
authors.forename: Larry R
authors.initials: LR
authors.lastname: Wechsler
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Switzer
authors.forename: Robert W
authors.initials: RW
authors.lastname: Mays
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002545:Brain Ischemia / Q000150:complications; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D059630:Mesenchymal Stem Cells / Q000502:physiology; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D020521:Stroke / Q000209:etiology / Q000628:therapy*; D014184:Transplantation, Homologous; D055815:Young Adult
keywords: clinical trial; ischemic stroke; multipotent stem cell; spleen; stem cell