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Are mesenchymal stem cell treatments FDA approved?

Published Sep 18, 2026Updated Sep 19, 2026Last verified Sep 18, 2026Requests recorded in this site’s own server logs, with the crawler identity checked by reverse DNS or IP range.Google3OpenAI1Yandex1First collected Sep 18, 2026Recent requestsGoogleSep 20, 2026OpenAISep 20, 2026GoogleSep 19, 2026GoogleSep 19, 2026YandexSep 18, 2026
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Quick 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.

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Answer

The approval was based on a single-arm study of 54 children with a 70% overall response rate at day 28 [7]. The FDA lists conditions with no approved stem cell products in its consumer alert [8].

Sources

  1. journalAdult Stem Cells – Stem Cells and the Future of Regenerative Medicine — National Research Council and Institute of Medicine (National Academies Press, via NCBI Bookshelf) · accessed Sep 20, 2026 · Evidence page
  2. journalMultipotent to Pluripotent Properties of Adult Stem Cells — Stem Cells International (Hindawi), via PubMed Central · accessed Sep 20, 2026 · Evidence page
  3. journalAdult stem cells and their trans-differentiation potential—perspectives and therapeutic applications — Journal of Molecular Medicine (Hombach-Klonisch et al.), via PubMed Central · accessed Sep 20, 2026 · Evidence page
  4. academicMinimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement — Cytotherapy 8(4):315-317 (Dominici et al.) · accessed Sep 20, 2026 · Evidence page
  5. journalContinuous 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 — Haematologica (Atsuta et al.) · accessed Sep 20, 2026 · Evidence page
  6. journalOne 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) — Haematologica · accessed Sep 20, 2026 · Evidence page
  7. governmentFDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients — U.S. Food and Drug Administration · accessed Sep 19, 2026 · Evidence page
  8. governmentConsumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes — U.S. Food and Drug Administration · accessed Sep 19, 2026 · Evidence page
  9. governmentPatient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells or Tissues — U.S. Food and Drug Administration · accessed Sep 19, 2026 · Evidence page
  10. governmentFirst stem-cell therapy recommended for approval in EU (press release) — European Medicines Agency · accessed Sep 20, 2026 · Evidence page
  11. governmentHoloclar – EPAR — European Medicines Agency · accessed Sep 20, 2026 · Evidence page
  12. organizationStem Cell Resources for Patients — International Society for Stem Cell Research (ISSCR) · accessed Sep 20, 2026 · Evidence page