Are Stem Cell Treatments Legal in Florida? A Physician’s Perspective
One of the most frequent questions I receive from patients is: “Are stem cell treatments legal in Florida?” The answer is yes — but with specific guidelines and requirements.
In July 2025, the Florida Legislature passed CS/CS/SB 1768, a bill authorizing licensed physicians to perform certain non‑FDA‑approved stem cell therapies under regulated conditions. This law allows physicians to administer regenerative treatments involving stem cells for three main categories: orthopedic conditions, pain management, and wound care. (2)
CS/CS/SB 1768 became effective July 1, 2025. It requires physicians offering these treatments to obtain written informed consent from patients, clearly stating that the procedures are not FDA approved. In addition, clinics and providers must meet specific standards for stem cell sourcing and ethical use. The law prohibits stem cells derived from fetal tissue or aborted embryos, ensuring that ethically controversial sources remain restricted. (2)
For physicians like myself, who have advocated for regenerative medicine in orthopedics and pain management for over 20 years, this legislation represents a significant step forward. Patients seeking regenerative options — for example, to potentially support cartilage repair in the knee, shoulder, hip, or spine — can now do so within a legal and regulated framework in the state of Florida. (1)
While many regenerative approaches are still being studied, some scientific evidence supports related biologic interventions. For instance, a pilot study evaluating injectable amniotic membrane/umbilical cord particulate demonstrated meaningful improvements in pain and physical function for patients with knee osteoarthritis. In this single‑center study of 20 adults, intra‑articular injection of amniotic/umbilical particulate significantly reduced knee pain and was associated with improved physical function over a 24‑week period. No adverse events were reported.
In summary, regenerative stem cell therapies are legal in Florida under regulated circumstances, and continued research is expanding our understanding of how these treatments may benefit patients with musculoskeletal conditions.
References
- Castellanos, Ramon, et al. “Injectable Amniotic Membrane/Umbilical Cord Particulate for Knee Osteoarthritis: A Prospective, Single‑Center Pilot Study.” Pain Medicine, vol. 20, no. 11, Nov. 2019, pp. 2283–2291. Oxford Academic, doi:10.1093/pm/pnz143. Accessed 2026.
- Florida Senate. CS/CS/SB 1768: Stem Cell Therapy. The Florida Senate, effective 1 July 2025, www.flsenate.gov/Session/Bill/2025/1768. Accessed 2026