Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-05 @ 6:33 PM
Study NCT ID:
NCT02961504
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements
Sponsor:
Healios K.K.
Organization:
Study Overview
Official Title:
Placebo-Controlled, Double-Blind, Phase 2/3 Efficacy and Safety Trial of HLCM051 (MultiStem®) in Patients With Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREASURE
Brief 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: