{"id":645,"slug":"are-mesenchymal-stem-cell-treatments-fda-approved","question":"Are mesenchymal stem cell treatments FDA approved?","intent":"informational","language":"en","url":"https://worldwiki.io/q/are-mesenchymal-stem-cell-treatments-fda-approved","entity":{"slug":"adult-stem-cell","name":"Adult Stem Cell","url":"https://worldwiki.io/entity/adult-stem-cell"},"answer":{"short_answer":"Only for a narrow use. In December 2024, the FDA approved remestemcel-L-rknd (Ryoncil), an MSC product made from donor bone marrow, for steroid-refractory acute graft-versus-host disease in patients aged 2 months and older. It was the first FDA-approved MSC therapy. No stem cell product is FDA-approved for orthopaedic conditions such as knee arthritis or back pain, or for neurological diseases, autism or anti-aging.","detailed_answer":"<p>The approval was based on a single-arm study of 54 children with a 70% overall response rate at day 28 <span class=\"ref\">[7]</span>. The FDA lists conditions with no approved stem cell products in its consumer alert <span class=\"ref\">[8]</span>.</p>","format":"paragraph","confidence":75,"verified_at":"2026-09-18 06:21:20","updated_at":"2026-09-18 15:21:20"},"sources":[{"id":106,"title":"Adult Stem Cells – Stem Cells and the Future of Regenerative Medicine","url":"https://www.ncbi.nlm.nih.gov/books/NBK223693/","publisher":"National Research Council and Institute of Medicine (National Academies Press, via NCBI Bookshelf)","type":"journal","accessed_at":"2026-09-19 18:01:31"},{"id":107,"title":"Multipotent to Pluripotent Properties of Adult Stem Cells","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC3876920/","publisher":"Stem Cells International (Hindawi), via PubMed Central","type":"journal","accessed_at":"2026-09-19 18:01:31"},{"id":108,"title":"Adult stem cells and their trans-differentiation potential—perspectives and therapeutic applications","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC2954191/","publisher":"Journal of Molecular Medicine (Hombach-Klonisch et al.), via PubMed Central","type":"journal","accessed_at":"2026-09-19 18:01:31"},{"id":109,"title":"Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement","url":"https://pubmed.ncbi.nlm.nih.gov/16923606/","publisher":"Cytotherapy 8(4):315-317 (Dominici et al.)","type":"academic","accessed_at":"2026-09-19 18:01:32"},{"id":110,"title":"Continuous and differential improvement in worldwide access to hematopoietic cell transplantation: activity has doubled in a decade with a notable increase in unrelated and non-identical related donors","url":"https://haematologica.org/article/view/haematol.2024.285002","publisher":"Haematologica (Atsuta et al.)","type":"journal","accessed_at":"2026-09-19 18:01:33"},{"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":111,"title":"FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-remestemcel-l-rknd-steroid-refractory-acute-graft-versus-host-disease-pediatric","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-18 18:00:49"},{"id":112,"title":"Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes","url":"https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-18 18:00:49"},{"id":113,"title":"Patient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells or Tissues","url":"https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/patient-and-consumer-warning-about-potential-serious-risks-harm-following-use-unapproved-products","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-18 18:00:49"},{"id":114,"title":"First stem-cell therapy recommended for approval in EU (press release)","url":"https://www.ema.europa.eu/en/documents/press-release/first-stem-cell-therapy-recommended-approval-eu_en.pdf","publisher":"European Medicines Agency","type":"government","accessed_at":"2026-09-19 18:01:34"},{"id":115,"title":"Holoclar – EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/holoclar","publisher":"European Medicines Agency","type":"government","accessed_at":"2026-09-19 18:01:35"},{"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"}],"published_at":"2026-09-18 06:21:20"}