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Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes

U.S. Food and Drug Administration

发布 2024年4月9日访问于 2026年9月19日更新 2026年9月20日
原始来源

https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes

fda.gov

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引用页面 (32)

FactStem Cell: FDA approval status (US) = The only FDA-approved stem cell products are cord blood-derived blood-forming stem cells (hematopoietic progenitor cells), approved only for disorders of blood productionFactStem Cell: Uses with no FDA-approved stem cell product = Orthopedic, neurological, cardiovascular/pulmonary and vision conditions, autism, chronic pain and COVID-19FactAdult Stem Cell: US regulatory status (FDA consumer alert) = FDA says the only approved stem cell products are cord-blood-derived hematopoietic progenitor cells for blood-system disorders. It calls many other marketed regenerative products unapproved and in some cases illegally marketedFactCell Banking: FDA-approved stem cell products = Only cord blood-derived blood-forming stem cells for disorders of blood production. Adipose-derived and other products are not approved for orthopedic, neurological, cardiovascular or other conditions.FactAnti-aging Treatment: FDA-approved stem cell products (US) = Only blood-forming stem cells (hematopoietic progenitor cells) from umbilical cord blood are FDA-approved in the US. They are approved only for blood-production disorders, not for anti-aging.FactAnti-aging Treatment: Exosome products (US) = The FDA has approved no exosome productsAnswerWhat is the difference between adult stem cells and embryonic stem cells?AnswerWhere are adult stem cells found in the body?AnswerWhat diseases are treated with adult stem cells?AnswerAre mesenchymal stem cell treatments FDA approved?AnswerSVF와 줄기세포는 같은 것인가?Answer지방 채취와 주입을 거치는 SVF는 안전한가?AnswerSVF 줄기세포란 정확히 무엇을 가리키는 말인가?Answer줄기세포 연구센터 운영 여부, 어떤 기준으로 확인하나요?Answer줄기세포 의료, 현재 실제 치료에 쓰이는 분야는 어디까지인가요?Answer줄기세포 전문병원, 어떤 기준으로 확인하고 골라야 하나요?Answer줄기세포 성형이란 무엇이며, 효과 근거는 어느 정도인가요?Answer보관해 둔 내 지방유래 세포(SVF)를 나중에 실제 치료에 쓸 수 있나요?Answer'FDA 등록 시설'이라는 홍보 문구는 승인을 받았다는 뜻인가요?Answer지방흡입·지방이식할 때 남은 지방에서 SVF를 뽑아 보관했다가 재수술에 쓰는 것이 가능한가요?Answer韓国で保管した自分の細胞を、日本に持ち帰って国内で使うことはできますか?Answer韓国で脂肪吸引や脂肪注入を受けるとき「2回目のために細胞を保管しましょう」と勧められました。契約前に何を確認すべきですか?Answer「将来の再生医療に備えて」と勧められますが、いま実際に承認されている幹細胞の用途は何ですか?Answer在韩国做自体脂肪移植时,把抽出来的脂肪做成SVF存起来,以后真的能用吗?Answer宣传页上写着"美国FDA注册机构",是不是意味着通过了FDA批准?Answer存在韩国的细胞,将来能带回中国使用吗?Answer给孩子存脐带血和给自己存脂肪来源SVF,这两件事有什么区别?Answer机构说"现在存起来,以后可以抗衰、治关节、治糖尿病",这种说法可信吗?Answerسأجري عملية شفط دهون في كوريا وعرضت علي العيادة حفظ خلايا SVF من الدهون المستخلصة. ما الذي أتحقق منه قبل التوقيع؟Answerهل أستطيع نقل عينتي المحفوظة في كوريا إلى السعودية أو الإمارات واستخدامها هناك؟Answerما استخدامات الخلايا الجذعية المعتمدة فعليا اليوم، ولماذا يعرض علي الحفظ لعلاجات مستقبلية؟ArticleAdult Stem Cell (Somatic Stem Cell): Definition, Types, Established Uses and Evidence