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

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Please use this identifier to cite or link to this item:http://hdl.handle.net/2115/70999

Title: Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial : Rationale and design
Authors: Osanai, Toshiya Browse this author →KAKEN DB
Houkin, Kiyohiro Browse this author →KAKEN DB
Uchiyama, Shinichiro Browse this author
Minematsu, Kazuo Browse this author
Taguchi, Akihiko Browse this author
Terasaka, Shunsuke Browse this author →KAKEN DB
Keywords: Cell therapy
ischemic stroke
clinical trial
Issue Date: 1-Jun-2018
Publisher: SAGE Publications
Journal Title: International journal of stroke
Volume: 13
Issue: 4
Start Page: 444
End Page: 448
Publisher DOI: 10.1177/1747493017743057
PMID: 29134924
Abstract: 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.
Rights: 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.
Type: article (author version)
URI: http://hdl.handle.net/2115/70999
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 長内 俊也

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