{"id":604,"slug":"is-stem-cell-therapy-fda-approved","question":"Is stem cell therapy FDA approved?","intent":"informational","language":"en","url":"https://worldwiki.io/q/is-stem-cell-therapy-fda-approved","entity":{"slug":"stem-cell-therapy","name":"Stem Cell Therapy","url":"https://worldwiki.io/entity/stem-cell-therapy"},"answer":{"short_answer":"Only for a few specific uses. The FDA says its approved stem cell products are cord blood-derived blood-forming cell products for disorders of the blood-forming system. Its approved-products register also lists Ryoncil, a mesenchymal stromal cell therapy approved in December 2024 for steroid-refractory acute GVHD in children, and Omisirge. The FDA warns that most other stem cell, cord blood, Wharton's jelly and exosome products marketed to consumers are not approved.","detailed_answer":"<p>You can check a product's status in the FDA's public list of approved cellular and gene therapy products.<span class=\"ref\">[2]</span> Listing a trial in a registry, or registering a firm with the FDA, does not mean a product is legally marketed.<span class=\"ref\">[1]</span></p>","format":"paragraph","confidence":75,"verified_at":"2026-09-18 06:21:20","updated_at":"2026-09-18 15:21:20"},"sources":[{"id":96,"title":"Important Patient and Consumer Information About Regenerative Medicine Therapies","url":"https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-18 18:00:38"},{"id":97,"title":"Approved Cellular and Gene Therapy Products","url":"https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-18 18:00:38"},{"id":98,"title":"One and a half million hematopoietic stem cell transplants: continuous and differential improvement in worldwide access with the use of non-identical family donors (Niederwieser D, et al., Haematologica 107(5):1045-1053)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9052915/","publisher":"Haematologica","type":"journal","accessed_at":"2026-09-19 18:01:25"},{"id":99,"title":"Stem Cell Resources for Patients","url":"https://www.isscr.org/patients","publisher":"International Society for Stem Cell Research (ISSCR)","type":"organization","accessed_at":"2026-09-19 18:01:26"},{"id":100,"title":"Graft-versus-host disease: MedlinePlus Medical Encyclopedia","url":"https://www.medlineplus.gov/ency/article/001309.htm","publisher":"U.S. National Library of Medicine (MedlinePlus)","type":"government","accessed_at":"2026-09-19 18:01:26"},{"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":103,"title":"FDA Approves Remestemcel-L-Rknd for Steroid-Refractory Acute Graft-Versus-Host Disease in Pediatric Patients","url":"https://www.ons.org/publications-research/voice/news-views/12-2024/fda-approves-remestemcel-l-rknd-steroid-refractory","publisher":"Oncology Nursing Society","type":"organization","accessed_at":"2026-09-19 18:01:29"},{"id":104,"title":"New legal category of 'advanced regenerative medicine treatment' in Korea's amended regenerative medicine law: comparative lessons from Japan (Yoon, Lee, Kim)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13083794/","publisher":"Stem Cell Reports","type":"journal","accessed_at":"2026-09-19 18:01:29"},{"id":105,"title":"Unproven stem cell therapy for macular degeneration (Ansari ZA, Kuriyan AE, Albini TA)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC5710873/","publisher":"Oncotarget","type":"journal","accessed_at":"2026-09-19 18:01:30"}],"published_at":"2026-09-18 06:21:20"}