In this guide
Key takeaways
- Every FDA-approved stem cell product treats a blood, immune or rare inherited disorder. They include cord blood transplants, gene-modified blood stem cells and one mesenchymal stromal cell product for a transplant complication in children.
- The FDA says no stem cell, exosome, Wharton's jelly or fat-derived product is approved for orthopedic, neurological, heart, lung or anti-aging uses.
- The approval of one MSC product (Ryoncil) does not stretch to other MSC products, other diseases or other ways of giving the cells.
- Getting treated in Colombia doesn't change a product's FDA status. Ask the clinic exactly which Colombian authorization covers the product it plans to use.
- You can check any product's status yourself in about five minutes using the FDA's public list.
“FDA-approved” may be the most stretched phrase in stem cell marketing. Some clinics use it to mean a device was cleared, some to mean the lab is registered, and some to mean a related product exists somewhere. Very few use it to mean what it actually says. The FDA keeps a public list of approved cellular and gene therapy products, so you don't need to take anyone's word for it. This guide goes through that list as of its September 2026 update, explains what each stem cell product is approved for, and shows how to check a claim yourself.
Why the approved list matters
An FDA approval isn't a general seal of quality. It covers one specific product, made by one manufacturing process, for one specific use (the indication), given in a specific way. Before granting it, the agency reviews clinical trial evidence that the product is safe and effective for that use. If any of those four elements changes, the approval no longer applies.
That's why it matters which list a clinic points to. The FDA's Approved Cellular and Gene Therapy Products page names more than 50 products. Most are not stem cell therapies at all. They are CAR-T cancer treatments, gene therapies delivered by viruses, engineered skin, and similar products. Only a minority of entries involve stem cells, and every one of those targets the blood or immune system.
An establishment that is “FDA registered” has filed paperwork listing itself with the agency. That is not an approval of any product or treatment. We cover the difference in What “FDA Registered” Does and Does Not Mean.
What's actually on the list
Here are the stem cell–based entries on the FDA's list, grouped by type. Product names are as the FDA lists them. Indications are simplified, so check each product's label for the exact wording.
| Group | Examples on the list | What they're used for |
|---|---|---|
| Cord blood (HPC, Cord Blood) | Allocord, Clevecord, Ducord, Hemacord, Regenecyte and several public cord blood bank products | Transplants that rebuild blood formation in disorders of the blood-forming system. The FDA's consumer alert says these are approved only for blood-production disorders. |
| Expanded cord blood | Omisirge | A processed cord blood product for certain patients with blood cancers who need a cord blood transplant |
| Gene-modified blood stem cells (the patient's own) | Casgevy, Lyfgenia, Zynteglo, Skysona, Lenmeldy, Kresladi, Waskyra | One-time treatments for specific inherited blood, immune or metabolic disorders, such as sickle cell disease and beta-thalassemia |
| Mesenchymal stromal cells | Ryoncil (remestemcel-L) | Steroid-refractory acute graft-versus-host disease (a transplant complication) in children 2 months and older |
| Combination with blood stem cells | Tregzi | An immunotherapy for transplant patients that includes blood-forming stem and progenitor cells |
It's also worth knowing how these products are given. The gene-modified therapies aren't simple injections. They're delivered in specialized transplant centers, usually after chemotherapy that clears space in the bone marrow so the modified cells can take hold. Cord blood transplants follow similar hospital-based protocols, with close monitoring for weeks afterward. That's a very different setting from an outpatient clinic offering same-day infusions, and it's one reason approval of these products says nothing about outpatient regenerative treatments.
The pattern is clear. Every product sits inside the world of blood and bone marrow transplantation, where stem cell medicine has decades of evidence behind it. The International Society for Stem Cell Research (ISSCR) describes blood stem cell transplantation as the best-established stem cell treatment, used for more than 50 years.
The list also includes MACI, a product made from a patient's own cultured cartilage cells that is implanted surgically. It isn't a stem cell product, and its approval covers specific cartilage defects rather than general osteoarthritis. If a clinic cites it as proof that knee injections work, ask how their product compares.
What none of them are approved for
The FDA has said plainly which uses are not approved. Its consumer alert on regenerative medicine products covers stem cell, exosome, fat-derived stromal vascular fraction, cord blood, Wharton's jelly and amniotic fluid products. It states that none are approved for:
- Orthopedic conditions such as osteoarthritis, back pain or knee pain
- Neurological disorders such as ALS, Alzheimer's, Parkinson's or stroke
- Heart and lung disease, including COPD
- Autism, macular degeneration, blindness, chronic pain or fatigue
- COVID-19 and its complications
The same alert says there are currently no FDA-approved exosome products. That matters because exosomes are often sold as a cell-free “next step.” Our coverage of the 2026 exosome crackdown explains how enforcement has developed.
A separate FDA page for patients considering regenerative medicine therapies lists harms reported with unapproved products. These include blindness, tumor formation, blood and bacterial infections, neurological events, and immune reactions. It also says that being charged for these products outside a clinical trial is a warning sign.
Why Ryoncil doesn't validate clinic MSC injections
When the FDA approved Ryoncil in December 2024, some clinic marketing presented it as proof that “MSCs are now FDA-approved.” That isn't what happened. According to the FDA's approval notice, the approval covers:
- One product. Mesenchymal stromal cells from donor bone marrow, made by one company's process
- One disease. Steroid-refractory acute graft-versus-host disease, a severe immune complication after a transplant
- One population. Children 2 months of age and older
- One evidence base. A multicenter study of 54 children with a single treatment group and no control group
None of that carries over to umbilical cord MSCs grown in a different lab, fat-derived cells, or injections into a knee or spine. Cells from different sources and labs can behave differently. That's why each product has to earn its own approval. Our explainers on FDA 351 vs 361 rules and culture-expanded cells go deeper into why.
One approved MSC product shows the field can produce real medicines. It doesn't show that every MSC product is one.
What this means if you're considering Colombia
Many people look abroad precisely because the treatment they want isn't approved in the US. That is a legitimate personal decision, and we have written about the reasons in Why the FDA Limits Stem Cell Therapy. But be clear about what changes when you cross a border and what doesn't:
The rulebook
Colombia has its own regulators and laws, led by INVIMA and the Ministry of Health. A product can be legal to offer there without FDA approval.
The evidence
A treatment that hasn't been proven in trials isn't proven in Colombia either. The biology is the same in Medellín as in Miami.
The FDA status
A product used abroad is still unapproved by the FDA for that use. US insurers generally won't treat it as standard care.
In Colombia, human organs, tissues and cells (componentes anatómicos) are governed by Decree 2493 of 2004. Under it, INVIMA certifies good practices at tissue and bone marrow banks. Exactly how lab-expanded cell products fit into Colombian rules is complex, and we explain it in our INVIMA regulation guide. The practical step is simple: ask the clinic in writing which Colombian authorization covers the specific product it plans to use, and ask for the document.
How to check a product's status yourself
- Get the exact product nameAsk the clinic for the product's name, its manufacturer or lab, and the source of the cells. “Our proprietary MSCs” is not an answer.
- Search the FDA listOpen the FDA's approved products page and search for the name. If it isn't there, it isn't an FDA-approved cellular product.
- Read the indicationIf it is on the list, open the product page and check what it's approved for. Approval for a blood disorder doesn't cover your knee.
- Don't treat registries as approvalsA ClinicalTrials.gov listing or an FDA establishment registration doesn't prove a product is legally marketed. The FDA says so directly. See our step-by-step trial lookup guide.
- Ask the FDA if you're unsureThe agency invites questions about regulatory status at ocod@fda.hhs.gov or 800-835-4709.
If what you find doesn't match what the clinic told you, that is useful information. A trustworthy provider describes an unapproved treatment as unapproved and explains its risks and evidence honestly. For a fuller vetting process, see how to verify a Colombian clinic and doctor yourself and the ISSCR's guidance for patients.
Frequently asked questions
Are any stem cell treatments FDA-approved?
Yes, but only a small group, and all of them treat blood, immune or rare inherited disorders. They include cord blood transplant products, gene-modified blood stem cell therapies, and one mesenchymal stromal cell product for a transplant complication in children.
Is there an FDA-approved stem cell treatment for knee arthritis or back pain?
No. The FDA's consumer alert states that stem cell, exosome, Wharton's jelly and fat-derived products are not approved for orthopedic conditions such as osteoarthritis, back pain or knee pain.
Does Ryoncil's approval mean MSC injections are now approved?
No. Ryoncil is approved for one condition, steroid-refractory acute graft-versus-host disease in children 2 months and older. The approval does not extend to other MSC products, other conditions or other routes of administration.
If a clinic says its lab is FDA registered, is the product approved?
No. Establishment registration is a listing requirement, not a review of safety or effectiveness. The FDA notes that registration and clinical trial listings do not prove a product is legally marketed.
Does getting treated in Colombia make an unapproved product safe?
No. Colombia has its own legal framework, so a product may be legal to offer there. But being legal there doesn't add evidence of safety or effectiveness. Ask the clinic which Colombian authorization covers the product and what the evidence shows for your condition.
Want help reading a clinic's claims?
If a clinic has told you its product is approved or “FDA-compliant,” send us what they said. We can talk through your options and what to verify before you commit to anything.
Talk through your options →Sources
- Approved Cellular and Gene Therapy Products — U.S. Food and Drug Administration
- Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes — U.S. Food and Drug Administration
- Important Patient and Consumer Information About Regenerative Medicine Therapies — U.S. Food and Drug Administration
- FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients — U.S. Food and Drug Administration
- Stem Cell Treatments — International Society for Stem Cell Research (ISSCR)
- Decreto 2493 de 2004 (componentes anatómicos) — Ministerio de Salud y Protección Social de Colombia
This article is general information, not medical advice, and it does not replace an evaluation by a licensed physician who knows your history. Most stem cell treatments discussed on this site are not approved by the FDA or proven in completed clinical trials for the conditions they are marketed for; outcomes are not guaranteed and risks are real. Regulations and registry tools change, so confirm details with the official sources linked above. Colombia Stem Cell Treatment is an independent information site, not a clinic. If you ask us to, we may share your inquiry with providers, who may compensate our network for introductions; see our terms for details. No affiliate links appear in this article.