{"id":1174,"slug":"为什么要去韩国做-国内的监管是怎么规定的-胶原酶分离在法规上有什么争议","question":"为什么要去韩国做？国内的监管是怎么规定的，胶原酶分离在法规上有什么争议？","intent":"local","language":"zh","url":"https://worldwiki.io/q/为什么要去韩国做-国内的监管是怎么规定的-胶原酶分离在法规上有什么争议","entity":{"slug":"svf-assisted-fat-grafting","name":"SVF-assisted Fat Grafting","url":"https://worldwiki.io/entity/svf-assisted-fat-grafting"},"answer":{"short_answer":"各国对SVF处理的监管归类并不一致。本条目来源中唯一明确的监管文件是美国FDA 2020年7月的最终指导原则《Regulatory Considerations for HCT/Ps: Minimal Manipulation and Homologous Use》（取代2017年11月版），其中用胶原酶消化分离SVF不属于“最小操作” [8]。因此有文献提出以非酶的术中机械分离方法作为可能的替代路径 [9]。中国大陆的具体规定不在本条目来源范围内，应直接向拟就诊机构和主管卫生行政部门核实。","detailed_answer":"<p>换句话说，“在某个国家可以做”并不等于“该做法已被证据充分支持”，也不等于在其他国家具有同样的合法路径。就诊前可向机构索取：执行分离的设备与方法说明、该项目在当地的合规依据、术者资质，以及并发症处理与复诊安排 [8][9]。</p><p>关于细胞类技术的伦理与临床转化，ISSCR发布有公开指南，可作为判断宣传是否过度的参考 [11]。</p>","format":"paragraph","confidence":75,"verified_at":null,"updated_at":"2026-09-20 17:11:10"},"sources":[{"id":242,"title":"Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-19 18:00:14"},{"id":133,"title":"Intraoperative Strategies for Minimal Manipulation of Autologous Adipose Tissue for Cell- and Tissue-Based Therapies: Concise Review (Trivisonno A et al.)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6877766/","publisher":"Stem Cells Translational Medicine / PubMed Central","type":"journal","accessed_at":"2026-09-19 18:01:44"},{"id":14,"title":"ISSCR Guidelines for Stem Cell Research and Clinical Translation","url":"https://www.isscr.org/guidelines","publisher":"International Society for Stem Cell Research","type":"organization","accessed_at":"2026-09-19 18:01:07"}],"published_at":"2026-09-20 08:11:10"}