Florida's New Stem Cell Law (HB 1617) — What It Means for You

In 2025, Florida became one of the first states in the nation to pass comprehensive legislation specifically addressing stem cell therapies. House Bill 1617 — signed into law and effective as of mid-2025 — establishes a formal regulatory framework for the practice of regenerative medicine in the state, with significant implications for patients, providers, and clinics. Understanding what the law does and does not do is essential for anyone considering stem cell treatment in Florida.

HB 1617 creates a defined pathway for the offering of "investigational" stem cell treatments outside of traditional FDA clinical trial structures. Under the law, licensed Florida physicians may administer certain stem cell therapies that have not yet received full FDA approval, provided specific conditions are met: patients must provide informed consent that explicitly acknowledges the investigational nature of the treatment, clinics must maintain detailed records of outcomes, and facilities must meet defined standards of practice. The law also establishes an oversight board and a registry for tracking patient outcomes across the state — a mechanism designed to accumulate real-world evidence while protecting patient safety.

The law does not, however, create a regulatory free-for-all. It explicitly prohibits the marketing of stem cell therapies with unsubstantiated claims of efficacy. Clinics cannot represent treatments as "FDA-approved" when they are not, and any claim of a specific outcome must be supported by documented clinical evidence. Providers who violate these requirements face significant penalties, including loss of licensure. In effect, the law distinguishes between responsible, supervised regenerative medicine practice and exploitative marketing — a distinction that consumer advocates and reputable clinic operators have both welcomed.

For patients, the practical meaning of HB 1617 is increased transparency and accountability. When you receive treatment at a licensed Florida regenerative medicine clinic operating under this framework, you have the right to detailed informed consent documentation, a clear explanation of the biological agents being used, and the assurance that your provider is operating within a regulated structure. You should ask your clinic directly how they are complying with HB 1617 requirements and what outcome tracking mechanisms they have in place.

At NexGenEsis, we operate in full compliance with Florida's regulatory framework and maintain rigorous standards for patient selection, biological agent sourcing, informed consent, and outcome documentation. We view HB 1617 not as a burden but as a validation of the approach we have always taken: evidence-informed, transparent, and patient-centered. If you have questions about how Florida's new stem cell law affects your treatment options, our team is available to walk you through the specifics as they apply to your situation.