title: [Phase III clinical trial using autologous mesenchymal stem cells for stroke patients].
abstract: We conduct a double-blind randomized placebo-controlled clinical trial (Phase III: confirmatory trial) of intravenous infusion of autologous mesenchymal stem cells for cerebral infarction patients. The objectives of this study were to examine feasibility, safety, and efficacy of cell therapy using auto serum-expanded autologous mesenchymal stem cells derived from bone marrow in the stroke patients. Inclusion criteria is (1) Cerebral infarction onset within 40 days, (2) Supra-tentorial cerebral infarction(NINDS-III 1990) diagnosed by MRI(or CT), MRA (3D-CTA or DSA), ECG, chest X-ray etc., (3) Classified under grade 4 or 5 of mRS (modified Rankin scale), (4) Age between 20 to 80, (5) The written informed consent from subjects and legal representative is provided.
authors.forename: Osamu
authors.initials: O
authors.lastname: Honmou
mesh_terms: D000328:Adult; D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods; D008875:Middle Aged; D044968:Regenerative Medicine / Q000379:methods / Q000639:trends; D012720:Severity of Illness Index; D020521:Stroke / Q000145:classification / Q000175:diagnosis / Q000628:therapy*; D000071939:Stroke Rehabilitation; D014182:Transplantation, Autologous