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Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements — TREASURE  

Stroke, Acute Clinical Trial

Official title:
Placebo-Controlled, Double-Blind, Phase 2/3 Efficacy and Safety Trial of HLCM051 (MultiStem®) in Patients With Ischemic Stroke

Clinical Trial Summary

The primary objectives of this study is to evaluate the efficacy of HLCM051 on functional outcome in subjects with acute ischemic stroke and to evaluate the safety of HLCM051 in subjects with acute ischemic stroke.

Clinical Trial Description

This is a randomized, placebo-controlled, double-blind, multicenter, phase 2/3 trial to evaluate the efficacy and safety of intravenous administration of HLCM051 compared with placebo in subjects with acute ischemic stroke (within 36 hours of onset). Japanese subjects who developed a subcortical ischemic stroke and are eligible to participate in the trial will be evaluated. Approximately 220 subjects will be randomized in a 1:1 ratio (HLCM051 group [n=110] or placebo group [n=110]) to receive a single infusion of HLCM051 or placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02961504
Study type Interventional
Source Healios K.K.
Contact
Status Completed
Phase Phase 2/Phase 3
Start date November 15, 2017
Completion date February 28, 2023
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