---
title: "Are mesenchymal stem cell treatments FDA approved?"
url: "https://worldwiki.io/q/are-mesenchymal-stem-cell-treatments-fda-approved"
type: "question"
language: "en"
intent: "informational"
entity: "Adult Stem Cell"
topic: "SVF & Adipose-derived Cells"
published: "2026-09-18 06:21:20"
updated: "2026-10-08 09:18:06"
---

# Are mesenchymal stem cell treatments FDA approved?

## 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.

## 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].

### Stem cells in cosmetic surgery

In cosmetic surgery, "stem cell" procedures almost always use [adipose-derived stem cells](/entity/adipose-derived-stem-cell). The stromal vascular fraction (SVF), which contains them, is separated from liposuctioned fat and mixed into the fat being grafted, as in [stem cell breast augmentation](/entity/stem-cell-breast-augmentation) and [stem cell fat grafting](/entity/stem-cell-fat-grafting).

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## Sources

1. [Adult Stem Cells – Stem Cells and the Future of Regenerative Medicine](https://www.ncbi.nlm.nih.gov/books/NBK223693/) — National Research Council and Institute of Medicine (National Academies Press, via NCBI Bookshelf) · evidence page: https://worldwiki.io/source/106
2. [Multipotent to Pluripotent Properties of Adult Stem Cells](https://pmc.ncbi.nlm.nih.gov/articles/PMC3876920/) — Stem Cells International (Hindawi), via PubMed Central · evidence page: https://worldwiki.io/source/107
3. [Adult stem cells and their trans-differentiation potential—perspectives and therapeutic applications](https://pmc.ncbi.nlm.nih.gov/articles/PMC2954191/) — Journal of Molecular Medicine (Hombach-Klonisch et al.), via PubMed Central · evidence page: https://worldwiki.io/source/108
4. [Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement](https://pubmed.ncbi.nlm.nih.gov/16923606/) — Cytotherapy 8(4):315-317 (Dominici et al.) · evidence page: https://worldwiki.io/source/109
5. [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](https://haematologica.org/article/view/haematol.2024.285002) — Haematologica (Atsuta et al.) · evidence page: https://worldwiki.io/source/110
6. [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)](https://pmc.ncbi.nlm.nih.gov/articles/PMC9052915/) — Haematologica · evidence page: https://worldwiki.io/source/98
7. [FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-remestemcel-l-rknd-steroid-refractory-acute-graft-versus-host-disease-pediatric) — U.S. Food and Drug Administration · evidence page: https://worldwiki.io/source/111
8. [Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes](https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes) — U.S. Food and Drug Administration · evidence page: https://worldwiki.io/source/112
9. [Patient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells or Tissues](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/patient-and-consumer-warning-about-potential-serious-risks-harm-following-use-unapproved-products) — U.S. Food and Drug Administration · evidence page: https://worldwiki.io/source/113
10. [First stem-cell therapy recommended for approval in EU (press release)](https://www.ema.europa.eu/en/documents/press-release/first-stem-cell-therapy-recommended-approval-eu_en.pdf) — European Medicines Agency · evidence page: https://worldwiki.io/source/114
11. [Holoclar – EPAR](https://www.ema.europa.eu/en/medicines/human/EPAR/holoclar) — European Medicines Agency · evidence page: https://worldwiki.io/source/115
12. [Stem Cell Resources for Patients](https://www.isscr.org/patients) — International Society for Stem Cell Research (ISSCR) · evidence page: https://worldwiki.io/source/99