What to know about soreness and treatment

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. 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.

3. FDA's public safety notification of 6 December 2019 states there are currently no FDA-approved exosome products, describes multiple reports of serious adverse events in Nebraska patients treated with unapproved products marketed as containing exosomes, and rejects the claim made by some clinics that exosomes fall outside drug and biological product regulation as 'simply untrue'.

   US Food and Drug Administration, Center for Biologics Evaluation and Research — Public Safety Notification on Exosome Products. , 2019.

4. FDA's list of licensed cellular and gene therapy products is the checkable public record of what has actually been approved; the orthopedic entry on it is MACI (autologous cultured chondrocytes on porcine collagen membrane), and the cord blood entries (HEMACORD, ALLOCORD, DUCORD and others) are hematopoietic products for blood disorders, not joint treatments.

   US Food and Drug Administration, Office of Therapeutic Products — Approved Cellular and Gene Therapy Products. , 2026.

5. MACI is FDA-licensed (STN BL 125603, Vericel Corporation) and is indicated for the repair of symptomatic, single or multiple FULL-THICKNESS cartilage defects of the knee with or without bone involvement in adults - a focal defect repair performed surgically, not a treatment for osteoarthritis and not an injection.

   US Food and Drug Administration — MACI (autologous cultured chondrocytes on porcine collagen membrane). , 2016.

6. On 18 December 2024 FDA approved RYONCIL (remestemcel-L-rknd), the first mesenchymal stromal cell therapy ever approved in the United States - for steroid-refractory acute graft-versus-host disease in pediatric patients 2 months and older, given as eight intravenous infusions. It is not an orthopedic product and does not make any joint injection approved.

   US Food and Drug Administration — FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease. , 2024.

7. The 2018 AAOS/NIH consensus work group recommended that minimally manipulated mixed cell preparations be called CELL THERAPY rather than stem cell therapy, and that their untested and uncharacterised nature be clearly communicated to patients and the public, because stem cells have properties these preparations do not meet.

   Chu CR, et al. — Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg, 2019. DOI: 10.5435/JAAOS-D-18-00305.