---
title: "Is stem cell therapy FDA approved?"
url: "https://worldwiki.io/q/is-stem-cell-therapy-fda-approved"
type: "question"
language: "en"
intent: "informational"
entity: "Stem Cell Therapy"
topic: "Stem Cell Treatment"
published: "2026-09-18 06:21:20"
updated: "2026-10-08 09:18:06"
---

# Is stem cell therapy FDA approved?

## 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.

## Answer

You can check a product's status in the FDA's public list of approved cellular and gene therapy products.[2] Listing a trial in a registry, or registering a firm with the FDA, does not mean a product is legally marketed.[1]

### 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).

## Related questions

- [Is stem cell therapy legal in South Korea?](https://worldwiki.io/q/is-stem-cell-therapy-legal-in-south-korea)
- [What conditions can stem cell therapy treat?](https://worldwiki.io/q/what-conditions-can-stem-cell-therapy-treat)
- [What is stem cell therapy used for?](https://worldwiki.io/q/what-is-stem-cell-therapy-used-for)
- [How do I know if a stem cell clinic is legitimate?](https://worldwiki.io/q/how-do-i-know-if-a-stem-cell-clinic-is-legitimate)
- [What are the risks of stem cell therapy?](https://worldwiki.io/q/what-are-the-risks-of-stem-cell-therapy)
- [What should I check before stem cell treatment in Korea?](https://worldwiki.io/q/what-should-i-check-before-stem-cell-treatment-in-korea)

## Sources

1. [Important Patient and Consumer Information About Regenerative Medicine Therapies](https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies) — U.S. Food and Drug Administration · evidence page: https://worldwiki.io/source/96
2. [Approved Cellular and Gene Therapy Products](https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) — U.S. Food and Drug Administration · evidence page: https://worldwiki.io/source/97
3. [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
4. [Stem Cell Resources for Patients](https://www.isscr.org/patients) — International Society for Stem Cell Research (ISSCR) · evidence page: https://worldwiki.io/source/99
5. [Graft-versus-host disease: MedlinePlus Medical Encyclopedia](https://www.medlineplus.gov/ency/article/001309.htm) — U.S. National Library of Medicine (MedlinePlus) · evidence page: https://worldwiki.io/source/100
6. [Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World (Fernández-Garza LE, et al., Pharmaceuticals 16(9):1334)](https://pmc.ncbi.nlm.nih.gov/articles/PMC10536665/) — Pharmaceuticals (MDPI) · evidence page: https://worldwiki.io/source/101
7. [Alofisel: EPAR](https://www.ema.europa.eu/en/medicines/human/EPAR/alofisel) — European Medicines Agency · evidence page: https://worldwiki.io/source/102
8. [FDA Approves Remestemcel-L-Rknd for Steroid-Refractory Acute Graft-Versus-Host Disease in Pediatric Patients](https://www.ons.org/publications-research/voice/news-views/12-2024/fda-approves-remestemcel-l-rknd-steroid-refractory) — Oncology Nursing Society · evidence page: https://worldwiki.io/source/103
9. [New legal category of 'advanced regenerative medicine treatment' in Korea's amended regenerative medicine law: comparative lessons from Japan (Yoon, Lee, Kim)](https://pmc.ncbi.nlm.nih.gov/articles/PMC13083794/) — Stem Cell Reports · evidence page: https://worldwiki.io/source/104
10. [Unproven stem cell therapy for macular degeneration (Ansari ZA, Kuriyan AE, Albini TA)](https://pmc.ncbi.nlm.nih.gov/articles/PMC5710873/) — Oncotarget · evidence page: https://worldwiki.io/source/105