“Stem cell therapy” for arthritis is one of the most heavily marketed treatments in orthopedics, and it is also one of the least supported by evidence. No stem cell or regenerative product is FDA-approved to treat any joint condition, the American Academy of Orthopaedic Surgeons says the evidence that it works is not yet there, and for that reason this practice does not offer it — we follow the evidence, and the evidence isn’t there yet.
Key Takeaways
- This practice does not offer stem cell injections for arthritis. We follow the evidence, and for stem cells it is not there yet.
- No stem cell or regenerative therapy is FDA-approved for any orthopedic condition. The FDA states these products have not been approved to treat osteoarthritis or knee, hip, back, neck, or shoulder pain, and it has received reports of blindness, tumor formation, and infections from unapproved products [1].
- The American Academy of Orthopaedic Surgeons notes that despite decades of research, there is not yet strong evidence that stem cell treatments are effective, and the FDA has issued warning letters calling some unapproved stem cell marketing dangerous and illegal [2].
- What is sold as “stem cells” is usually bone marrow (BMAC) or processed-fat preparations; the actual stem cell content is small and variable.
- We do offer treatments with real evidence behind them: exercise (an AAOS strong recommendation) and other established nonsurgical care, PRP for selected patients (rated only “Limited” by AAOS), and surgery when it is appropriate.
What does “stem cell therapy” actually mean?
In orthopedic marketing, “stem cell” injections are usually bone marrow (BMAC) or processed-fat preparations, and the actual number of stem cells they contain is small, variable, and seldom measured.
“Stem cell therapy” sounds like a single, well-defined treatment, but in orthopedic marketing it is an umbrella term for several very different injections. In practice, the products advertised this way are most often bone marrow aspirate concentrate (BMAC), where marrow is drawn from the pelvis and spun down, or processed fat (adipose) preparations, where cells are isolated from liposuction. Some clinics inject amniotic or umbilical-cord products instead.
What these preparations have in common is that the true stem cell content is small, variable, and rarely measured. The honest version of this conversation is plain: when a clinic says “stem cells,” what is actually in the syringe is usually a concentrated mix of cells and growth factors, only a tiny fraction of which are stem cells — and the number is almost never disclosed. That distinction matters, because the marketing promise (cells that rebuild cartilage) is far stronger than what is in the injection or what it has been shown to do.
What does the evidence actually show?
The two most authoritative US bodies on this question — the American Academy of Orthopaedic Surgeons and the FDA — both reach the same conclusion: the evidence that stem cell injections treat arthritis is not there, and no such product is approved.
What the AAOS says. The American Academy of Orthopaedic Surgeons, the main US specialty body for orthopedic surgeons, is direct in its patient guidance: “Despite decades of research, there is not yet strong evidence that stem cell treatments are effective” [2]. AAOS also notes that some stem cell products carry “limited evidence of clinical benefit,” and that the FDA has issued warning letters stating that the marketing of some providers’ stem cell treatments is “dangerous and illegal” [2]. For comparison, AAOS does not even give a strong endorsement to PRP, a far better-studied injection: it rates PRP only “Limited,” its second-weakest tier, after downgrading the recommendation because the evidence was inconsistent [3].
What the FDA says. The FDA’s patient warning is unusually specific. It states that “regenerative medicine therapies have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain,” and that the agency “has received reports of blindness, tumor formation, infections, and more… due to the use of these unapproved products” [1]. Knee and hip osteoarthritis — exactly the conditions these injections are marketed for — are named outright.
This is not a case of one cautious skeptic against an emerging consensus. The specialty body and the regulator agree, and they have agreed for years. That is the entire basis for our position.
If the evidence isn’t there, why do clinics sell it anyway?
The honest answer is cash-pay economics: because insurance and Medicare do not cover stem cell injections, they are sold directly to patients for thousands of dollars per injection, with no insurer scrutinizing whether they work.
If the evidence is this thin, why are stem cell injections advertised on so many billboards and clinic websites? The most honest answer is economics, not conspiracy. Because no insurer or Medicare plan covers these treatments, they are cash-pay — frequently several thousand dollars per injection, paid directly by the patient. There is no insurance reviewer asking for the published evidence, no coverage policy to satisfy, and a strong financial incentive to offer a treatment that patients are willing to pay for out of pocket.
That does not make every clinic dishonest, and some are genuinely trying to help patients who have run out of options. But it does mean the money runs ahead of the science. When a treatment is profitable and unregulated by coverage rules, the burden is on the clinic to show you the evidence — not on you to disprove the marketing. A practice that sells you something the FDA has specifically warned about, without walking you through that warning, is not giving you the full picture.
How does it compare with the treatments we do offer?
Here is how the marketed promise of stem cell injections compares with the treatments we actually offer, judged by the same standard — the published evidence:
| Treatment | FDA-approved for arthritis? | What the evidence shows | Do we offer it? |
|---|---|---|---|
| Stem cell / regenerative injections (BMAC, adipose, amniotic) | No — not approved for any orthopedic condition [1] | AAOS: not yet strong evidence of effectiveness; FDA reports serious harms [1][2] | No |
| Platelet-rich plasma (PRP) | Not specifically approved; widely studied | Mixed; AAOS rates it only “Limited” — may help some patients [3] | Yes, for selected patients, offered honestly |
| Exercise & established nonsurgical care | N/A — standard of care | AAOS strongly recommends exercise to reduce pain and improve function [4] | Yes |
| Joint replacement surgery | N/A — established procedure | Considered when pain limits daily life and nonsurgical care has not helped [5] | Yes, when appropriate |
What we offer instead
Saying no to stem cells is only useful if there is a better answer, and there is. For arthritis of the knee and hip, we build a plan around treatments that have earned their place:
- Established nonsurgical care. Exercise is one of the most strongly supported treatments for arthritis — the AAOS strongly recommends supervised, unsupervised, or aquatic exercise over no exercise to reduce pain and improve function [4]. This, along with weight optimization and activity changes, is the foundation. See our nonsurgical treatment options.
- PRP, offered honestly. Platelet-rich plasma is far better studied than stem cells, but it is not a sure thing: the evidence is genuinely mixed and AAOS rates it only “Limited” [3]. We offer it as a reasonable option for selected patients while being clear about what it can and cannot do. See PRP and biologic injections.
- Surgery when it is appropriate. When arthritis is advanced and nonsurgical care has stopped working, joint replacement is a proven operation, not an experiment. Learn about knee arthritis and hip arthritis and how we decide when surgery is the right step.
What I tell my patients is simple: I would rather offer you a treatment with honest, modest evidence than an expensive one with a great story and none. If a genuinely effective regenerative therapy is proven for arthritis, we will offer it. Until then, we will not sell you hope by the syringe.
Questions to ask any clinic offering stem cells
If you are considering a clinic that offers stem cell injections for arthritis, these four questions will tell you most of what you need to know:
- Is it FDA-approved for arthritis? The honest answer is no — no stem cell or regenerative product is approved for any orthopedic condition [1]. If a clinic implies otherwise, that is a red flag.
- What, exactly, is being injected? Ask for the specific product (BMAC, adipose, amniotic, umbilical-cord), and how many stem cells it actually contains and how that was measured.
- What published evidence supports it for my condition? Ask for peer-reviewed studies in your specific joint, not testimonials or a clinic’s own before-and-after photos.
- What does it cost, and why isn’t it covered? If insurance and Medicare will not pay for it, ask the clinic to explain why — the usual reason is that the evidence does not yet meet the bar for coverage.
References
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. Content current as of 04/08/2024. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies
- American Academy of Orthopaedic Surgeons (OrthoInfo). Use of Stem Cells in Orthopaedics. https://orthoinfo.aaos.org/en/treatment/use-of-stem-cells-in-orthopaedics/
- American Academy of Orthopaedic Surgeons. Management of Osteoarthritis of the Knee (Non-Arthroplasty): Evidence-Based Clinical Practice Guideline. 3rd ed. 2021 (PRP rated “Limited”). Summary: Brophy RH, Fillingham YA. J Am Acad Orthop Surg. 2022;30(9):e721-e729. PMID: 35383651.
- American Academy of Orthopaedic Surgeons. Management of Osteoarthritis of the Knee (Non-Arthroplasty): Evidence-Based Clinical Practice Guideline. 3rd ed. 2021 (exercise — Strong recommendation). https://www.aaos.org/oak3cpg
- American Academy of Orthopaedic Surgeons (OrthoInfo). Total Knee Replacement; Total Hip Replacement. https://orthoinfo.aaos.org/en/treatment/total-knee-replacement/