Common questions about joint regeneration Peoria have plain answers

Sources

1. A cross-sectional study contacted 273 of 317 US centres offering direct-to-consumer stem-cell therapy, posing as a 57-year-old man with knee osteoarthritis. The mean advertised price of a unilateral same-day stem-cell knee injection was $5,156 (SD $2,446), and centres claimed a mean clinical efficacy of 82% (SD 9.6%) - a figure with no support in the published evidence. The gap between the quoted number and the trial data is the single most useful thing a patient can be told before a consultation.

   Piuzzi NS, et al. — The Stem-Cell Market for the Treatment of Knee Osteoarthritis: A Patient Perspective.. The journal of knee surgery, 2018. DOI: 10.1055/s-0037-1604443.

2. Medicare's National Coverage Determination covers autologous platelet-rich plasma ONLY for chronic non-healing diabetic, pressure or venous WOUNDS, and only under Coverage with Evidence Development inside an approved clinical research study. There is no Medicare coverage pathway for PRP as a treatment for osteoarthritis or any other joint indication, which is why these injections are quoted as cash prices.

   Centers for Medicare & Medicaid Services — Autologous Platelet-rich Plasma (Coverage with Evidence Development). CMS.gov, 2012.

3. FDA states plainly that no stem cell, exosome, stromal vascular fraction, umbilical cord blood, Wharton's jelly or amniotic-fluid product has been approved for the treatment of ANY orthopedic condition - it names osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain and shoulder pain individually. The only FDA-approved stem cell products in the United States are cord-blood-derived blood-forming stem cells for disorders of the hematopoietic system, and there are currently no FDA-approved exosome products.

   US Food and Drug Administration, Center for Biologics Evaluation and Research — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. FDA, 2020.

4. The RESTORE trial - a participant-, injector- and assessor-blinded RCT of 288 adults aged 50+ with symptomatic medial knee OA (Kellgren-Lawrence 2-3) - compared three weekly intra-articular PRP injections against saline placebo, with co-primary endpoints of 12-month knee pain and medial tibial cartilage volume on MRI. PRP did not beat placebo on either. It is the single best-designed test of the specific claim that PRP changes joint structure, and it was negative.

   Bennell KL, et al. — Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial.. JAMA, 2021. DOI: 10.1001/jama.2021.19415.

5. A four-arm, multicentre, single-blind phase 2/3 randomized trial of 480 knee OA patients (KL II-IV) compared autologous bone marrow aspirate concentrate, autologous adipose stromal vascular fraction and allogeneic umbilical-cord-tissue mesenchymal stromal cells against a corticosteroid injection control. At 12 months NONE of the three orthobiologic injections was superior to another, or to the corticosteroid control, and none of the four groups showed a significant change in MRI osteoarthritis score from baseline. No procedure-related serious adverse events occurred.

   Mautner K, et al. — Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial.. Nature medicine, 2023. DOI: 10.1038/s41591-023-02632-w.

6. The AAOS clinical practice guideline summary on SURGICAL management of knee osteoarthritis - the other end of the ladder, and the honest comparator for anyone told a biologic injection will let them avoid an operation.

   Srivastava AK, et al. — American Academy of Orthopaedic Surgeons Clinical Practice Guideline Summary of Surgical Management of Osteoarthritis of the Knee.. The Journal of the American Academy of Orthopaedic Surgeons, 2023. DOI: 10.5435/JAAOS-D-23-00338.