Stem Cell Centers Claim High Efficacy for Treatment of Knee OA Despite Lack of Evidence

    An estimated 9.9 million adults in the US have osteoarthritis (OA) of the knee, leading to pain, disability, and a general decline in quality of life. One of the treatment options for knee OA that is rapidly gaining popularity is stem cell therapy.

    In their advertising, stem cell centers claim a high success rate for this treatment – from 55% to 100% – according to research presented at the 2018 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). Of the 65 centers that provided pricing information to treat OA of the knee, the cost ranged from $1,150 to $12,000, with an average of $5,000 per injection.

    However, peer-reviewed evidence for the efficacy of this treatment is lacking.

    “Our role as orthopaedic surgeons is to provide accurate, credible information on treatment options to our patients,” said George Muschler, MD, Professor of Orthopaedic Surgery and Director at the Regenerative Medicine Laboratory at Cleveland Clinic. “Recent systematic reviews of cellular therapies for the treatment of knee OA (over 400 papers screened) have found poor levels of evidence for the efficacy of these treatments to date. Current evidence does not justify the rapid rate of growth for these therapies.”

    For the study presented at the AAOS Annual Meeting, researchers contacted 317 U.S. centers that offer direct-to-consumer stem cell musculoskeletal treatments. All communications were via phone or email. The 273 centers that were successfully contacted were asked for information on same-day stem cell injections for OA of the knee, including clinical efficacy and cost.

    Sixty-five centers provided pricing for a same-day stem cell unilateral knee injection. The mean cost for each therapy was $5,156, with prices ranging from $1,150 to $12,000. Fourteen centers charged less than $3,000 and 10 clinics charged more than $8,000 per injection. Insurance does not cover stem cell treatments; the cost is paid 100% by the patient.

    Thirty-six centers provided data on treatment effectiveness, with the mean marketed clinical efficacy of 82.2%. Ten clinics claimed 90% to 100% efficacy, 15 claimed 80% to 90% efficacy, 10 claimed 70% to 80% efficacy, and 1 claimed 55% or more clinical efficacy. The researchers found no correlation between treatment costs and marketed clinical efficacy.

    “The claim of ‘stem cell’ therapy carries a high level of expectations for the potential benefits, but research is still many years away from providing clear evidence of effective treatment to patients,” said Nicolas S. Piuzzi, MD, lead author and Clinical Scholar in Orthopaedic Regenerative Medicine and Cellular Therapy in the Department of Orthopaedic Surgery at Cleveland Clinic.

    “As clinicians and researchers, we have ethical, scientific, legal and regulatory concerns. Patients need to be aware of the status of research within the field. If they receive information from anyone offering treatment that claims an 80% to 100% successful recovery, they should be concerned in observance of published peer-reviewed evidence.”

    The study was also published in the July 24, 2017, issue of The Journal of Knee Surgery.


    Piuzzi N, Ng M, Khlopas A, Chughtai M, Mont M, Muschler G. The Stem Cell Market for the Treatment of Knee Osteoarthritis: A Patient Perspective (Poster P0147). Presented at the 2018 Annual Meeting of the American Academy of Orthopaedic Surgeons, March 6-10, 2018, New Orleans, Louisiana.

    Piuzzi NS, Ng M, Chughtai M, Khlopas A, Ng K, Mont MA, Muschler GF. The stem-cell market for the treatment of knee osteoarthritis: a patient perspective. J Knee Surg 2017 Jul 24. doi: 10.1055/s-0037-1604443.