Conservative care

Stem cell injections for knee arthritis: what the FDA says

If you have knee arthritis, you've probably seen the ads. Before you spend thousands of dollars, here's what the FDA wants patients to know.

Ads for “stem cell,” “regenerative” or “exosome” injections promise to regrow cartilage and help you avoid surgery. Patients often bring them to me and ask whether they should try one. I understand the appeal. Nobody wants surgery if a shot could fix the problem. But patients deserve the facts.

What the FDA says

The U.S. Food and Drug Administration states plainly that regenerative medicine therapies have not been approved to treat any orthopedic condition, including osteoarthritis.1 The FDA has also received reports of serious harm from unapproved products, including infections, blindness and tumor formation. It warns that if you're being charged for one of these products outside a clinical trial, you may be getting a product illegally.1

What these injections cost you

These injections are usually not covered by insurance and can cost thousands of dollars. Just as important, they can cost you time while the arthritis keeps progressing.

What does help knee arthritis

The American Academy of Orthopaedic Surgeons reviewed the research on non-surgical treatment and found:2

  • Exercise and physical therapy are strongly recommended.
  • Weight loss is recommended for patients who are overweight.
  • Cortisone injections can provide short-term relief.
  • Hyaluronic acid (“gel”) injections help some patients, though results vary.

Platelet-rich plasma (PRP), made from your own blood, is one I now recommend for many patients. In a 2025 analysis of 18 randomized trials, PRP improved knee pain and function more than placebo.3 Read more about PRP injections and my guide to knee injections.

If you're considering a clinical trial

Legitimate research is underway. A real clinical trial is registered at ClinicalTrials.gov, and it doesn't charge you to take part in the experimental treatment. If you're unsure about an offer, bring it to your orthopedic surgeon.

When injections are no longer enough

When arthritis has worn away the cartilage, no injection can put it back. That's when a robotic partial knee or total knee replacement becomes the conversation. Request a consultation to find out where you are.

Sources
  1. U.S. Food and Drug Administration. Important patient and consumer information about regenerative medicine therapies.
  2. American Academy of Orthopaedic Surgeons. Management of Osteoarthritis of the Knee (Non-Arthroplasty): Evidence-Based Clinical Practice Guideline, 3rd ed. 2021.
  3. Bensa A, et al. Platelet-rich plasma for knee osteoarthritis: a systematic review and meta-analysis of randomized placebo-controlled trials. Am J Sports Med. 2025;53(3):745–754.

This article is for general education and is not medical advice. Talk with your surgeon about your own situation.

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