2024-03-29T15:39:21Zhttps://eprints.lib.hokudai.ac.jp/dspace-oai/requestoai:eprints.lib.hokudai.ac.jp:2115/709992022-11-17T02:08:08Zhdl_2115_20040hdl_2115_121Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial : Rationale and designOsanai, ToshiyaHoukin, KiyohiroUchiyama, ShinichiroMinematsu, KazuoTaguchi, AkihikoTerasaka, ShunsukeCell therapyischemic strokeclinical trial490Rationale: 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.SAGE PublicationsJournal Articleapplication/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documentapplication/vnd.openxmlformats-officedocument.wordprocessingml.documenthttp://hdl.handle.net/2115/70999https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/70999/3/IntJStroke13_444.pdfhttps://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/70999/2/Suplementary_table1.docxhttps://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/70999/1/Suplementary_table2.docx1747-4930International journal of stroke1344444482018-06-01enginfo:pmid/29134924info:doi/10.1177/1747493017743057Toshiya 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.author