{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T05:23:40Z","timestamp":1788931420197,"version":"build-2803163510"},"reference-count":15,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2017,11,14]],"date-time":"2017-11-14T00:00:00Z","timestamp":1510617600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Stroke"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>MultiStem\u00ae (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\u00ae 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\u00ae for treatment of ischemic stroke.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Sample size<\/jats:title>\n                    <jats:p>Estimated sample size is 220 (110 patients per group), which has 90% power at 5% significance level.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and design<\/jats:title>\n                    <jats:p>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\u201320 at baseline will be randomized 1:1 to receive a single intravenous infusion of MultiStem\u00ae or placebo within 18\u201336\u2009h of stroke onset.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study outcomes<\/jats:title>\n                    <jats:p>Primary outcome in this study is the proportion of patients with an excellent outcome at day 90 defined by the functional assessment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov (NCT02961504).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The TREASURE trial will provide a novel treatment option and expand the therapeutic window for patients with stroke if the results are positive.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1747493017743057","type":"journal-article","created":{"date-parts":[[2017,11,14]],"date-time":"2017-11-14T08:29:05Z","timestamp":1510648145000},"page":"444-448","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":21,"title":["Treatment evaluation of acute stroke for using in regenerative cell elements (TREASURE) trial: Rationale and design"],"prefix":"10.1177","volume":"13","author":[{"given":"Toshiya","family":"Osanai","sequence":"first","affiliation":[{"name":"Department of Neurosurgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiyohiro","family":"Houkin","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichiro","family":"Uchiyama","sequence":"additional","affiliation":[{"name":"International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuo","family":"Minematsu","sequence":"additional","affiliation":[{"name":"National Cerebral and Cardiovascular Center, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiko","family":"Taguchi","sequence":"additional","affiliation":[{"name":"Department of Regenerative Medicine Research, Institute of Biomedical Research and Innovation, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunsuke","family":"Terasaka","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Faculty of Medicine and Graduate School of Medicine, 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