Common questions about a sore joint and clinic care

Sources

1. FDA states in its consumer alert that the only FDA-approved stem cell products in the United States are blood-forming stem cells derived from umbilical cord blood, approved for disorders of the blood-forming system, and that NONE of these products - stem cells, stromal vascular fraction, umbilical cord blood, Wharton's jelly or amniotic fluid - has been approved for the treatment of any orthopedic condition, including osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain or shoulder pain.

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

2. A 2016 analysis of internet marketing found widespread direct-to-consumer promotion of unapproved stem cell interventions by businesses based in the United States - not only in countries with lax medical regulation - and concluded regulators must better oversee the marketplace.

   Turner L, et al. — Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry. Cell Stem Cell, 2016. DOI: 10.1016/j.stem.2016.06.007.

3. Hundreds of US businesses and clinics market unproven and unlicensed stem cell-based interventions, and many of them appear to violate the federal regulations that govern human cell and tissue products.

   Turner L, et al. — The US Direct-to-Consumer Marketplace for Autologous Stem Cell Interventions. Perspect Biol Med, 2018. DOI: 10.1353/pbm.2018.0024.

4. In 96 patients, concentrated bone marrow aspirate contained a mean of 26.3 million nucleated cells per mL but only about 1,422 colony-forming units of connective tissue progenitors, and the nucleated cell count had negligible predictive value for how many progenitor cells were actually present (r-squared 0.28).

   Muench LN, et al. — Nucleated Cell Count Has Negligible Predictive Value for the Number of Colony-Forming Units for Connective Tissue Progenitor Cells (Stem Cells) in Bone Marrow Aspirate Harvested From the Proximal Humerus During Arthroscopic Rotator Cuff Repair. Arthroscopy, 2021. DOI: 10.1016/j.arthro.2021.01.064.

5. 21 CFR 1271.10(a) sets the four criteria a human cell or tissue product must meet to be regulated SOLELY under section 361 of the Public Health Service Act: it must be minimally manipulated; intended for homologous use only, as reflected by labeling and advertising; not combined with another article beyond water, crystalloids or a preserving agent; and either have no systemic effect and not depend on the metabolic activity of living cells, or else be for autologous use, use in a close blood relative, or reproductive use.

   US Code of Federal Regulations, Title 21 — 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act. , 2004.

6. In a 480-patient, four-arm, multicenter randomized phase 2/3 trial, none of three orthobiologic cell injections - autologous bone marrow aspirate concentrate, autologous adipose stromal vascular fraction, or allogeneic umbilical cord tissue-derived mesenchymal stromal cells - was superior to any other, or to a corticosteroid injection control, on pain at 12 months.

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

7. In orders issued 26 December 2024 and announced 8 January 2025, a federal court permanently banned the co-founders of the Stem Cell Institute of America and their companies from marketing any regenerative medicine treatment, and ordered $5,155,146 in refunds and civil penalties. The court found on summary judgment that they published false and misleading advertisements about the efficacy and approval of stem cell injections for osteoarthritis, neuropathy and joint pain; their clinic charged up to $5,000 per injection and the customers were almost exclusively elderly and disabled people.

   US Federal Trade Commission — Stem Cell Institute Co-Founders and Companies Banned from Marketing Stem Cell Treatments and Ordered to Pay More Than $5.1 Million for Refunds and Civil Penalties. , 2025.