NCT02961504

Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Healios K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
BIOLOGICAL	HLCM051	Within 18 to 36 hours after the onset of ischemic stroke, subjects will receive a single dose of 1.2 billion HLCM051 cells to be intravenously administered
BIOLOGICAL	Placebo	Within 18 to 36 hours after the onset of ischemic stroke, subjects will receive a single dose of placebo to be intravenously administered

Timeline

• Start date: 2017-11-15
• Primary completion: 2021-03-31
• Completion: 2023-02-28
• First posted: 2016-11-11
• Last updated: 2024-01-17

Locations

1 site across 1 country: Japan