{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T17:23:14Z","timestamp":1793467394743,"version":"4.5.0"},"reference-count":30,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2023,9,27]],"date-time":"2023-09-27T00:00:00Z","timestamp":1695772800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Cereb Blood Flow Metab"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:p>Effective treatments for stroke after the acute phase remain elusive. Muse cells are endogenous, pluripotent, immune-privileged stem cells capable of selectively homing to damaged tissue after intravenous injection and replacing damaged\/lost cells via differentiation. This randomized, double-blind, placebo-controlled trial enrolled ischemic stroke patients with modified Rankin Scale (mRS) \u22653. Randomized patients received a single intravenous injection of an allogenic Muse cell-based product, CL2020 (n\u2009=\u200925), or placebo (n\u2009=\u200910), without immunosuppressant, 14\u201328\u2009days after stroke onset. Safety (primary endpoint: week 12) and efficacy (mRS, other stroke-specific measures) were assessed up to 52\u2009weeks. Key efficacy endpoint was response rate (percentage of patients with mRS \u22642 at week 12). To week 12, 96% of patients in the CL2020 group experienced adverse events and 28% experienced adverse reactions (including one Grade 4 status epilepticus), compared with 100% and 10%, respectively, in the placebo group. Response rate was 40.0% (95% CI, 21.1\u201361.3) in the CL2020 group and 10.0% (0.3\u201344.5) in the placebo group; the lower CI in the CL2020 group exceeded the preset efficacy threshold (8.7% from registry data). This randomized placebo-controlled trial demonstrated CL2020 is a possible effective treatment for subacute ischemic stroke.<\/jats:p>\n                  <jats:p>Registry information: JAPIC Clinical Trials Information site (JapicCTI-184103, URL: https:\/\/www.clinicaltrials.jp\/cti-user\/trial\/ShowDirect.jsp?japicId=JapicCTI-184103 ).<\/jats:p>","DOI":"10.1177\/0271678x231202594","type":"journal-article","created":{"date-parts":[[2023,9,27]],"date-time":"2023-09-27T15:16:51Z","timestamp":1695827811000},"page":"2029-2039","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":51,"title":["Randomized placebo-controlled trial of CL2020, an allogenic muse cell\u2013based product, in subacute ischemic stroke"],"prefix":"10.1177","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9282-6499","authenticated-orcid":false,"given":"Kuniyasu","family":"Niizuma","sequence":"first","affiliation":[{"name":"Department of Neurosurgical Engineering and Translational Neuroscience, Graduate School of Biomedical Engineering, Tohoku University, Sendai, Japan"},{"name":"Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan"},{"name":"Department of Neurosurgical Engineering and Translational Neuroscience, Tohoku University Graduate School of Medicine, Sendai, Japan"},{"name":"Research Division of Muse Cell Clinical Research, Tohoku University Hospital, Sendai, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin-Ichiro","family":"Osawa","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan"},{"name":"Department of Physical Medicine and Rehabilitation, Tohoku University School of Medicine, Sendai, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidenori","family":"Endo","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin-Ichi","family":"Izumi","sequence":"additional","affiliation":[{"name":"Department of Physical Medicine and Rehabilitation, Tohoku University School of Medicine, Sendai, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kota","family":"Ataka","sequence":"additional","affiliation":[{"name":"Department of Physical Medicine and Rehabilitation, Tohoku University School of Medicine, Sendai, Japan"},{"name":"Department of Rehabilitation, Tohoku University Hospital, Sendai, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiro","family":"Hirakawa","sequence":"additional","affiliation":[{"name":"Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masao","family":"Iwano","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Research and Development Division, Life Science Institute, Inc., Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teiji","family":"Tominaga","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, 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Good outcome rate after 3 months for patients with mild\/moderate cerebral infarction. 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