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Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes

U.S. Food and Drug Administration

Published Apr 9, 2024accessed Sep 18, 2026Updated Sep 19, 2026
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https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes

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Cited by (19)

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?AnswerHow can I tell if a stem cell clinic is legitimate?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?ArticleAdult Stem Cell (Somatic Stem Cell): Definition, Types, Established Uses and Evidence