By Vivonyx · Last reviewed: October 2026
"Is it FDA approved?" is probably the most common question people ask about stem cell therapy. The answer isn't a simple yes or no, because "FDA approved" means something narrower than most people think.
Here's what approval covers and what "not approved" does and doesn't tell you.
Plenty of things you use aren't "FDA approved"
Vitamins, fish oil, and other dietary supplements never go through FDA approval before they're sold. The FDA says plainly that under federal law it "is not authorized to approve dietary supplements for safety and effectiveness before they are marketed" [1].
So "not FDA-approved" describes one review process, not whether something has value.
What approval actually is
FDA approval covers one product for one specific use (called an indication). It isn't a stamp on a whole category like "stem cells."
The FDA keeps a public list of approved cell and gene therapy products [2]. It includes several blood-forming (hematopoietic) products made from umbilical cord blood, approved for disorders that affect blood production and not for other uses [2][3].
In December 2024, the FDA approved Ryoncil, the first mesenchymal stromal cell (MSC) therapy in the U.S. It's approved for one situation: steroid-refractory acute graft-versus-host disease in children 2 months and older after a stem cell transplant [4]. It's a real milestone, but it doesn't carry over to other products or uses.
How cells and tissues are regulated: two paths
The FDA calls these products HCT/Ps (human cells, tissues, and cellular and tissue-based products). They follow one of two paths.
The "361" tissue path. Some HCT/Ps are regulated only under Section 361 of the Public Health Service Act and the rules in 21 CFR Part 1271. They don't need premarket approval. To qualify, a product has to meet all of the listed criteria, including being minimally manipulated and intended for homologous use, meaning it does the same basic job in the recipient that it did in the donor [5]. There's also a rule about living cells: if the cells' activity is how the product works, it generally qualifies only when it comes from the patient, a close blood relative, or is for reproductive use [5].
The "351" drug and biologic path. Products that don't meet those criteria are regulated as drugs or biologics. They need an Investigational New Drug application (IND) to be studied in people and a license before they can be marketed. The FDA's guidance explains how it reads "minimal manipulation" and "homologous use" [6].
Where does Wharton's jelly fit? A common belief is that it can't be approved because it's "just a tissue." The FDA's own materials don't support that. FDA consumer guidance names Wharton's jelly among the products not approved for any orthopedic condition, such as knee, back, or shoulder pain [3]. It also says the FDA has repeatedly told clinics and manufacturers that these products need an IND to be given legally [7]. In other words, the FDA generally treats them as 351 products that could go through approval for a specific use. So far, none has for orthopedic or pain uses.
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"Not approved" isn't the same as "not studied"
Umbilical cord and Wharton's jelly MSCs are being studied in registered clinical trials. A few examples from ClinicalTrials.gov:
NCT02580695: a randomized, double-blind Phase 1/2 trial of umbilical cord MSCs in knee osteoarthritis (Chile, completed) [8]
NCT05061030: a placebo-controlled Phase 1/2 trial of Wharton's jelly MSCs in children and teens with type 1 diabetes (Sweden) [9]
NCT04288934: a Phase 1 trial comparing two MSC sources, including Wharton's jelly, in spinal cord injury (Jordan, completed) [10]
When we searched ClinicalTrials.gov for Wharton's jelly MSC studies, we found 67 listings. Most were early-phase (Phase 1 or 1/2), which mainly look at safety and dosing. Only a handful were Phase 3 [11]. Research is active, but early.
What to do with all this
"Is it FDA approved?" is a good start, but it's not the only question. Better ones are: what exactly is the product, how is it made, what does the published research show for my situation, and is it part of a registered study? For the full list, see 8 Questions Worth Asking First. For background, see The Science.
FAQ
Is stem cell therapy FDA approved? Some specific products are, for specific uses: cord-blood blood-forming products for certain blood disorders, and Ryoncil for a pediatric transplant complication [2][4]. None is approved for orthopedic conditions [3].
Are supplements FDA approved? No. The FDA isn't authorized to approve dietary supplements for safety and effectiveness before they're sold [1].
Is Wharton's jelly exempt from FDA approval because it's a tissue? Generally no, not for uses like joint or back pain. The FDA says these products need an IND to be given legally and haven't been approved for orthopedic conditions [3][7].
Does "not FDA-approved" mean no research exists? No. Many umbilical cord and Wharton's jelly MSC trials are registered, though most are early-phase [11].
Still have questions?
If you'd like help working through a product, a study, or your own situation, email hello@vivonyx.com. Or ask the Vivonyx AI assistant any time.
Related reading
Education only, not medical advice. Regulatory status can change; check the cited FDA pages for the latest. Talk with your doctor before making health decisions.
References
U.S. Food and Drug Administration. Information for Consumers on Using Dietary Supplements. https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements
U.S. Food and Drug Administration. 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. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes (current as of Apr 9, 2024). 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. FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease (Dec 18, 2024). https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host
21 CFR 1271.10. Are my HCT/P's regulated solely under section 361 of the PHS Act? https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-A/section-1271.10
U.S. Food and Drug Administration. Regulatory Considerations for HCT/Ps: Minimal Manipulation and Homologous Use, Guidance (July 2020). https://www.fda.gov/media/109176/download
U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies (current as of Apr 8, 2024). https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies
ClinicalTrials.gov. NCT02580695. https://clinicaltrials.gov/study/NCT02580695
ClinicalTrials.gov. NCT05061030. https://clinicaltrials.gov/study/NCT05061030
ClinicalTrials.gov. NCT04288934. https://clinicaltrials.gov/study/NCT04288934
ClinicalTrials.gov search, "Wharton's jelly" mesenchymal (67 studies; searched Oct 12, 2026). https://clinicaltrials.gov/search?term=%22wharton%27s%20jelly%22%20mesenchymal