Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements

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.

Timeline

Start

2017-11-15

Primary completion

2021-03-31

Completion

2023-02-28

Outcome

Missed primary endpoint

paper There were no between-group differences in primary and secondary end points. PMID 38227308 ↗

paper 12 [11.5%] vs 10 [9.8%], P = .90 PMID 38227308 ↗

Publications

• Houkin K, Osanai T, Uchiyama S, Minematsu K, Taguchi A, Maruichi K, Niiya Y, Asaoka K, Kuga Y, Takizawa K, Haraguchi K, Yoshimura S, Kimura K, Tokunaga K, Aoyama A, Ikawa F, Inenaga C, Abe T, Tominaga A, Takahashi S, Kudo K, Fujimura M, Sugiyama T, Ito M, Kawabori M, Hess DC, Savitz SI, Hirano T; TREASURE Study Investigators. Allogeneic Stem Cell Therapy for Acute Ischemic Stroke: The Phase 2/3 TREASURE Randomized Clinical Trial. JAMA Neurol. 2024 Feb 1;81(2):154-162. doi: 10.1001/jamaneurol.2023.5200.
• Osanai T, Houkin K, Uchiyama S, Minematsu K, Taguchi A, Terasaka S. Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial: Rationale and design. Int J Stroke. 2018 Jun;13(4):444-448. doi: 10.1177/1747493017743057. Epub 2017 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MultiStem	Cell therapy	1.2e+09 cells	Intravenous

Indications