{"title":"Dark Clouds Looming Over Regenerative Medicine in Japan.","authors":"Hiroshi Kawaguchi","doi":"10.1089/scd.2025.0012","DOIUrl":null,"url":null,"abstract":"<p><p>Japan's regenerative medicine sector has encountered major challenges, underscored by the recent failures of products such as HeartSheet and Collategene. These setbacks expose critical weaknesses in the fast-track approval system, raising concerns about patient safety and the scientific robustness of product evaluations. Despite strong governmental support, addressing these fundamental issues is essential for the future success of regenerative medicine in Japan.</p>","PeriodicalId":94214,"journal":{"name":"Stem cells and development","volume":" ","pages":"149-151"},"PeriodicalIF":2.0000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Stem cells and development","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1089/scd.2025.0012","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/6 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Japan's regenerative medicine sector has encountered major challenges, underscored by the recent failures of products such as HeartSheet and Collategene. These setbacks expose critical weaknesses in the fast-track approval system, raising concerns about patient safety and the scientific robustness of product evaluations. Despite strong governmental support, addressing these fundamental issues is essential for the future success of regenerative medicine in Japan.
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