Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial : Rationale and design

Osanai, Toshiya; Houkin, Kiyohiro; Uchiyama, Shinichiro; Minematsu, Kazuo; Taguchi, Akihiko; Terasaka, Shunsuke

Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial : Rationale and design

Osanai, Toshiya; Houkin, Kiyohiro; Uchiyama, Shinichiro et al.

International journal of stroke, 2018, 13(4), 444-448

Permalink : https://hdl.handle.net/2115/70999

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論文情報

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アクセス権	open access
URI	https://hdl.handle.net/2115/70999
タイトル	Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial : Rationale and design
著者	Osanai, Toshiya ; Houkin, Kiyohiro ; Uchiyama, Shinichiro ; Minematsu, Kazuo ; Taguchi, Akihiko ; Terasaka, Shunsuke
e-Rad_Researcher 90622788 著者名 Osanai, Toshiya
e-Rad_Researcher 90229146 著者名 Houkin, Kiyohiro
著者名 Uchiyama, Shinichiro
著者名 Minematsu, Kazuo
著者名 Taguchi, Akihiko
e-Rad_Researcher 10447055 著者名 Terasaka, Shunsuke
言語	英語
キーワード	Cell therapy
	ischemic stroke
	clinical trial
発行日	2018-06-01
出版者	SAGE Publications
収録物名	International journal of stroke
巻(号)	13(4)
ページ	444-448
抄録	Rationale: MultiStem® (HLM051) is one of the promising allogenic cell products for acute ischemic stroke with strong evidence. A previous phase 2 randomized, double-blind, placebo-controlled, multicenter dose-escalation trial showed the safety of MultiStem® for acute ischemic stroke, with a time window beyond that of rt-PA and endovascular thrombectomy. We aim to obtain stronger evidence and to show the efficacy of the MultiStem® for treatment of ischemic stroke. Sample size: Estimated sample size is 220 (110 patients per group), which has 90% power at 5% significance level. Methods and design: TREASURE is a randomized, double-blind, placebo-controlled, multicenter phase 2/3 trial. The trial will be done at 31 medical centers in Japan. Patients with acute ischemic stroke including motor or speech deficit defined by a National Institution of Health Stroke Scale (NIHSS) score of 8-20 at baseline will be randomized 1:1 to receive a single intravenous infusion of MultiStem® or placebo within 18-36 h of stroke onset. Study outcomes: Primary outcome in this study is the proportion of patients with an excellent outcome at day 90 defined by the functional assessment. Trial registration: ClinicalTrials.gov (NCT02961504). Conclusion: The TREASURE trial will provide a novel treatment option and expand the therapeutic window for patients with stroke if the results are positive.
資源タイプ	学術雑誌論文
出版タイプ	Accepted Manuscript
権利情報	Toshiya Osanai, Kiyohiro Houkin, Shinichiro Uchiyama, Kazuo Minematsu, Akihiko Taguchi, and Shunsuke Terasaka, Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial : Rationale and design., International Journal of Stroke (Vol 13, Issue 4) pp.444-448. Copyright © 2018, SAGE Publications. Reprinted by permission of SAGE Publications.
PISSN	1747-4930
関連情報	PMID 29134924
関連情報 (isVersionOf)	出版社版DOI https://doi.org/10.1177/1747493017743057