{"id":962,"slug":"脂肪干细胞治疗在中国大陆能做吗-国内有获批上市的脂肪干细胞产品吗","question":"脂肪干细胞治疗在中国大陆能做吗？国内有获批上市的脂肪干细胞产品吗？","intent":"local","language":"zh","url":"https://worldwiki.io/q/脂肪干细胞治疗在中国大陆能做吗-国内有获批上市的脂肪干细胞产品吗","entity":{"slug":"adipose-derived-stem-cell","name":"Adipose-derived Stem Cell","url":"https://worldwiki.io/entity/adipose-derived-stem-cell"},"answer":{"short_answer":"本页收录的监管事实只覆盖韩国（MFDS批准Queencell、Cupistem）、欧盟（Alofisel已于2024年12月13日撤回上市许可）和美国（2023年一项全球综述中未列出任何获FDA批准的脂肪来源间充质干细胞产品），不包含中国大陆的审批与备案信息。中国境内是否有对应获批产品、哪些机构可开展相关临床研究，需要到国家药品监督管理局的药品目录和卫生健康部门公布的干细胞临床研究备案信息中自行核对。[5][6][8]","detailed_answer":"<p>可以直接核实的国外记录有三条：韩国MFDS批准的两款自体产品Queencell（2010）与Cupistem（2012）；欧盟对异体产品达伐妥赛（Alofisel）的上市许可于2018年3月23日授予、2024年12月13日应持有人申请撤回；2023年一项关于全球已获批间充质干细胞疗法的综述中未列出获FDA批准的脂肪来源间充质干细胞产品。[5][6]</p><p>关于中国大陆的合规口径，本页资料无法回答。建议以两类官方公开信息为准：药品是否获批，查国家药品监督管理局；医疗机构是否可以开展干细胞临床研究，查主管部门公布的备案名单。对外出具的宣传材料不能替代这两类查询结果。</p>","format":"paragraph","confidence":75,"verified_at":null,"updated_at":"2026-09-20 17:11:10"},"sources":[{"id":101,"title":"Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World (Fernández-Garza LE, et al., Pharmaceuticals 16(9):1334)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10536665/","publisher":"Pharmaceuticals (MDPI)","type":"journal","accessed_at":"2026-09-19 18:01:27"},{"id":102,"title":"Alofisel: EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/alofisel","publisher":"European Medicines Agency","type":"government","accessed_at":"2026-09-19 18:01:28"},{"id":247,"title":"Ninth Circuit Confirms: Certain Stem Cell Products Require FDA Premarket Approval","url":"https://www.cooley.com/news/insight/2024/2024-10-31-ninth-circuit-confirms-certain-stem-cell-products-require-fda-premarket-approval","publisher":"Cooley LLP","type":"industry","accessed_at":"2026-09-19 18:00:20"}],"published_at":"2026-09-20 08:11:10"}