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

Effective Date: July 1, 2025
Florida is taking a big step forward in regenerative medicine with the Stem Cell Therapy Act (HB 1617). This new law creates a structured path for licensed physicians to offer investigational stem cell therapies outside of FDA-approved clinical trials—while ensuring strong safety, transparency, and ethical safeguards.

If you’ve been following the growth of regenerative medicine, this is an important change that opens new possibilities for patients seeking innovative treatments right here in Florida.

The Big Picture

Until now, many advanced stem cell treatments were only available through FDA-approved trials or in other states/countries with different rules. HB 1617 now allows qualified MDs and DOs to offer these therapies directly—as long as they follow strict quality, ethical, and safety standards.

Key Protections & Requirements

1. Source Integrity

All cells must come from FDA-registered facilities and be accredited by the Association for the Advancement of Blood & Biotherapies (AABB).
This ensures the material is handled by trusted, regulated sources.

2. Manufacturing Standards

Cell processing must follow Current Good Manufacturing Practice (cGMP) standards—federal rules that guarantee purity, potency, and consistency.

3. Informed Consent

Patients must receive:

• A plain-language summary of the procedure

• A clear explanation of risks, benefits, and alternatives

• Written consent confirming they understand the treatment is investigational

4. Ethical Sourcing

The law bans embryonic stem cells. Approved sources include donated umbilical cord and placental tissue, making it non-controversial and ethically sound.

5. Physician Oversight

The therapy must fit within the doctor’s specialty. For example:

• An orthopedic surgeon could treat a joint injury

• A neurologist could address nerve damage
  This ensures patients get care from experts in the relevant field.