Which Stem Cell Treatments Are FDA Approved? The Full List
This is the list clinics do not link to. It is short, it is specific, and reading it is the fastest way to understand what is genuinely established medicine and what is not.
Approved cord blood products
These are licensed for haematopoietic stem cell transplantation — rebuilding blood and immune systems in patients with disorders affecting blood production.
| Product | Licence holder |
|---|---|
| ALLOCORD | SSM Cardinal Glennon Children’s Medical Center |
| CLEVECORD | Cleveland Cord Blood Center |
| DUCORD | Duke University School of Medicine |
| HEMACORD | New York Blood Center |
| HPC, Cord Blood | Clinimmune Labs, University of Colorado |
| HPC, Cord Blood | MD Anderson Cord Blood Bank |
| HPC, Cord Blood | LifeSouth Community Blood Centers |
| HPC, Cord Blood | Bloodworks |
Conditions treated with these products include acute and chronic leukaemias, lymphomas, myelodysplastic syndromes, inherited metabolic disorders, sickle cell disease, thalassaemia, aplastic anaemia and severe combined immunodeficiency.
Related approved cell and gene therapies
The wider category of approved cellular therapies also includes CAR-T products for certain blood cancers, and gene therapies using haematopoietic stem cells for conditions such as sickle cell disease and beta thalassaemia. These are hospital treatments delivered at specialist centres, not clinic infusions.
What is not on the list
Nothing is FDA approved for:
- Knee, hip, shoulder, or spine osteoarthritis
- Back pain or degenerative disc disease
- Rotator cuff, tendon or ligament injury
- COPD or pulmonary fibrosis
- Autism
- Type 1 or type 2 diabetes
- Peripheral neuropathy
- Erectile dysfunction
- Hair loss
- Anti-ageing, longevity, or general wellness
- Long COVID
Additionally: stromal vascular fraction from fat is not lawfully marketable for these uses, and no exosome product has FDA approval despite widespread sale.
Bone marrow transplantation
A common source of confusion. Bone marrow and peripheral blood stem cell transplantation for cancers and blood disorders is long-established, evidence-based medicine performed in hospitals. It has been standard care for decades.
Clinics sometimes gesture at this history — "stem cell therapy has been used successfully for over 50 years" — to imply their knee injection shares that pedigree. It does not. They are different cell types, different procedures, and different evidence bases. The only thing they share is a word.
How to check for yourself
The FDA maintains a public list of approved cellular and gene therapy products. Any clinic claiming approval should be able to name which listed product they use and which approved indication applies to you. Both answers must exist, and both must match your condition.
If the product is not on the list, or the approved indication is a blood disorder and you are being treated for your knee, the treatment is not FDA approved for your use — regardless of how the clinic phrases it.
What this list does not mean
Absence from this list does not mean a treatment is useless or dangerous. It means nobody has demonstrated to a regulator that it works. Some unapproved treatments will eventually be approved; that is how medicine progresses. The point is to know which category you are buying from, and to price the uncertainty accordingly.
Sources
- US Food and Drug Administration — Approved Cellular and Gene Therapy Products.
- US Food and Drug Administration — Warning letters and consumer alerts on exosome products and unapproved regenerative medicine.
- International Society for Stem Cell Research — Patient Handbook on Stem Cell Therapies.
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Medical disclaimer
This article is for general information and is not medical advice. We are not a healthcare provider and do not diagnose or treat any condition. Most stem cell treatments discussed here are not FDA approved for these uses, outcomes vary, and no result is guaranteed. Always speak with a licensed physician who knows your history. See our medical disclaimer and how we make money.