Which Regenerative Medicine Products Are FDA-Approved?

Very few, and none for joint pain. As of the FDA's September 17, 2026 update, its list of licensed cellular and gene therapy products has 54 entries, most of them for cancers, rare genetic disorders, and blood or immune conditions (U.S. Food and Drug Administration [FDA], 2026). No regenerative product is FDA-approved for osteoarthritis, back pain, or tendon problems, and the stem cell, exosome, and Wharton's jelly injections commonly marketed to consumers are not on the list (FDA, 2021).

What This Means

"Regenerative medicine" is a broad label, not a regulatory category. It covers cell-based products, tissue-engineered products, gene therapies, and blood-derived preparations such as platelet-rich plasma (PRP). FDA status depends on the specific product and the specific use. A product can be approved for one narrow indication and remain unapproved for everything else.

A handful of approved products are relevant to musculoskeletal and skin care. MACI, made from a patient's own cartilage cells (autologous cultured chondrocytes) grown on a collagen membrane, is approved for the repair of symptomatic, full-thickness cartilage defects of the knee in adults (FDA, 2024a). It requires surgery to harvest the cells and a second procedure to implant them. LAVIV (azficel-T), made from a patient's own skin fibroblasts, is on the list for the appearance of moderate to severe nasolabial fold wrinkles (FDA, 2026). Umbilical cord blood products are approved for disorders that affect blood production and not for other uses (FDA, 2021).

In December 2024, the FDA approved Ryoncil (remestemcel-L), the first mesenchymal stromal cell product, for children with steroid-refractory acute graft-versus-host disease, a serious immune complication after a bone marrow transplant (FDA, 2024b; Giebel, 2025). It is given by intravenous infusion in a hospital setting. That approval does not extend to joints, skin, or aging.

Everything else marketed under the regenerative label sits in one of two groups. PRP is prepared with FDA-cleared devices, but nearly all are cleared for mixing with bone graft material, so an office injection is off-label (Beitzel et al., 2015). Stem cells, stromal vascular fraction (fat-derived cells), amniotic fluid, Wharton's jelly, and exosomes offered outside an FDA-overseen clinical trial are unapproved (FDA, 2021).

Candidacy

For approved products, the FDA label defines who qualifies. MACI is limited to adults with a confirmed full-thickness cartilage defect of the knee (FDA, 2024a). Ryoncil is limited to children 2 months and older with a specific transplant complication (FDA, 2024b).

For unapproved products, there is no FDA-defined candidate. The legitimate route to an investigational product is a clinical trial with FDA oversight (FDA, 2021). Candidacy for anything at PrimeCell Regenerative is decided by a physician after an evaluation, not by the product.

Clinical Evaluation

An evaluation at PrimeCell Regenerative includes a history, a musculoskeletal and neurological exam, a review of prior imaging, and ultrasound imaging when appropriate. I want to know which structure is generating the pain before recommending anything.

We also tell patients which regulatory category any option falls into: FDA-approved for that use, off-label use of an FDA-cleared device, or investigational. You should not have to guess.

Available Options

For most joint, tendon, and back pain, the mainstream options come first: physical therapy and exercise, weight management, activity changes, oral or topical anti-inflammatory medications, bracing, corticosteroid injections, and hyaluronic acid injections for the knee. Surgery, including arthroscopy or joint replacement, is appropriate for some people.

Beyond those, the options are MACI for the specific cartilage defects on its label (FDA, 2024a), off-label PRP, or enrollment in a registered clinical trial of an investigational product. Which of these makes sense depends on the findings, not on what is available to sell.

Benefits, Limitations and Risks

FDA approval means a product's safety and effectiveness were reviewed for a specific use, with labeling, manufacturing standards, and required adverse-event reporting. The limitations are real: indications are narrow, costs are high, and a product such as MACI involves two surgical procedures.

Unapproved products carry different risks. The FDA has received reports of blindness, tumor formation, neurological events, and serious infections linked to unapproved regenerative products, along with contamination from processing and failure to work when approved options were available (FDA, 2021). Off-label PRP is made from your own blood, but preparation methods and platelet concentrations vary widely between systems (Beitzel et al., 2015), and any injection carries a risk of pain, bleeding, and infection.

What the Evidence Shows

What it does establish: the products on the FDA list met the agency's standards for their labeled uses (FDA, 2026). Ryoncil's approval rested on a multicenter, single-arm study in 54 children with steroid-refractory acute graft-versus-host disease (FDA, 2024b). The FDA has stated plainly that no regenerative therapy is approved for orthopedic conditions (FDA, 2021).

What it does not establish: an approval for one condition does not show that a similar cell product works for another. It does not show that clinic-marketed stem cell or exosome products are safe or effective. And a product described as "FDA registered," or a study listed on ClinicalTrials.gov, is not the same as an approved product; the FDA notes that these claims are often used to suggest compliance that does not exist (FDA, 2021).

Recovery / Next Steps

If you are offered a regenerative product, ask for the exact product name and manufacturer. Check it against the FDA's approved list (FDA, 2026) and confirm the approved use matches your condition. If it is offered as part of a trial, ask for the trial registration and whether the study is under an FDA investigational new drug application. If you had a problem after receiving one of these products, you can report it to the FDA's MedWatch program (FDA, 2021).

Orlando Considerations

Since July 1, 2025, Florida law has allowed physicians to use certain stem cell therapies not approved by the FDA in orthopedics, wound care, and pain management, under specific sourcing, manufacturing, and informed-consent requirements (Fla. Stat. § 458.3245, 2025). State law does not make those products FDA-approved and does not change federal requirements. Florida patients still benefit from asking which category a product falls into before agreeing to anything.

Frequently Asked Questions

Is any stem cell product FDA-approved for knee or joint pain?

No. The FDA states that no regenerative medicine therapy has been approved for any orthopedic condition, including osteoarthritis, tendonitis, disc disease, and knee, hip, back, neck, or shoulder pain (FDA, 2021). MACI is approved for specific full-thickness cartilage defects of the knee, but it is a surgically implanted cartilage-cell product, not a stem cell injection (FDA, 2024a).

Is PRP FDA-approved?

The devices used to prepare PRP are FDA-cleared, mostly for mixing platelet-rich preparations with bone graft material. Injecting PRP into a joint or tendon in the office is considered off-label use (Beitzel et al., 2015). Clearance of the device does not establish that the injection works for a given condition.

What was the first FDA-approved mesenchymal stem cell product?

Ryoncil (remestemcel-L), approved on December 18, 2024, for children 2 months and older with steroid-refractory acute graft-versus-host disease (FDA, 2024b; Giebel, 2025). It is not approved for any orthopedic, cosmetic, or anti-aging use.

How can I check whether a product is FDA-approved?

Ask for the exact product name and manufacturer, then look for it on the FDA's list of approved cellular and gene therapy products (FDA, 2026). Confirm that the approved use matches your condition. A product being "FDA registered" or listed on ClinicalTrials.gov does not mean it is approved (FDA, 2021).

This article is general education, not medical advice. Outside the specific FDA-approved products and uses named above, stem cell, exosome, and similar regenerative products are investigational outside FDA-approved clinical trials and are not FDA-approved to cure, treat, or prevent disease. Individual results vary. Options are discussed after a medical evaluation.

Medically reviewed by Kenny Chantasi, DO.

References

Beitzel, K., Allen, D., Apostolakos, J., Russell, R. P., McCarthy, M. B., Gallo, G. J., Cote, M. P., & Mazzocca, A. D. (2015). US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine. The Journal of Knee Surgery, 28(1), 29–34. https://doi.org/10.1055/s-0034-1390030

Fla. Stat. § 458.3245 (2025). http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0458/Sections/0458.3245.html

Giebel, B. (2025). A milestone for the therapeutic EV field: FDA approves Ryoncil, an allogeneic bone marrow-derived mesenchymal stromal cell therapy. Extracellular Vesicles and Circulating Nucleic Acids. https://doi.org/10.20517/evcna.2025.02

U.S. Food and Drug Administration. (2021, June 3). 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. (2024a, August 26). MACI (autologous cultured chondrocytes on porcine collagen membrane). https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/maci-autologous-cultured-chondrocytes-porcine-collagen-membrane

U.S. Food and Drug Administration. (2024b, December 18). Summary basis for regulatory action: RYONCIL (remestemcel-L-rknd). https://www.fda.gov/media/185192/download

U.S. Food and Drug Administration. (2026, September 17). Approved cellular and gene therapy products. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products

Last medically reviewed: September 23, 2026

If you want to know where a specific regenerative option stands with the FDA, or whether any of it fits your situation, a consultation is the place to sort that out. Bring prior imaging and records if you have them.

Related reading

• Where Do the Stem Cells Used in Therapy Come From?
• How PRP Is Used for Joint Pain
• What Are the Risks of Regenerative Medicine?
• What Questions Should You Ask Before Trying Regenerative Medicine?

More questions answered on the PrimeCell patient blog, or see frequently asked questions.

Related services at PrimeCell

PrimeCell is a physician-led practice in Orlando. Candidacy for any procedure is determined at an in-person evaluation.