Florida’s New Stem Cell Law: What It Signals for Physicians, Patients and the Future of Regenerative Medicine

Something important changed in Florida on July 1: the state passed a law (Senate Bill SB‑1768) that allows licensed physicians to offer certain stem cell treatments that are not yet FDA-approved — but only for specific uses (orthopedics, wound care, and pain management) and only if strict rules are followed.

This law matters beyond Florida because patient interest in regenerative care is growing. Doctors everywhere should understand what the law allows, what it requires, and how it connects to stem cell preservation and future therapies.

• What the law allows: Licensed physicians in Florida may use non‑FDA‑approved biologic products containing stem or other human cells or tissues for orthopedic, wound care, and pain management indications, within their scope of practice and subject to compliance rules.

• Sourcing and manufacturing rules: Biologics must come from afterbirth placental/perinatal sources or other ethically obtained human tissue (explicitly excluding fetal/embryo‑derived cells). Suppliers must operate in an FDA‑registered facility and meet accreditation and manufacturing standards.

• Accreditations and standards required: Suppliers must be accredited by organizations such as AABB, NMDP, or AATB, follow current Good Manufacturing Practices (cGMP), and provide post‑thaw viability reports for each treatment lot.

• Informed consent and transparency: Marketing must clearly state that these therapies are not FDA‑approved. Detailed, documented informed consent is required, explaining risks, alternatives, and regulatory status.

• Penalties for noncompliance: Violations (e.g., misrepresenting products, using banned cell sources, or failing supplier checks) can lead to felony charges and medical license revocation.

• For patients: If you’re considering regenerative treatments, expect clearer disclosure about what a product is, where it came from, and whether it’s FDA‑approved. Ask your provider for documentation of supplier accreditation and post‑thaw viability reports. If you plan to preserve biological tissue (cord blood or placenta), this law highlights the increasing value of high‑quality banking and documentation.

• For physicians: Even if you don’t practice in Florida, this law signals where the market is moving. You should understand sourcing standards, how to evaluate supplier quality, and how to discuss realistic benefits and risks with patients. Keep detailed consent records and verify supplier accreditation and cGMP compliance.

• For people thinking about stem cell banking: This law emphasizes the importance of banking tissues using providers that maintain strict chain‑of‑custody, accredited processing, and viability testing. Banking perinatal tissue (placenta, umbilical cord) under certified conditions can preserve options for future therapies.

• Perinatal stem cells come from afterbirth tissues like the placenta and umbilical cord. These cells are attractive to clinicians because they’re relatively easy to collect at birth and can have immune‑friendly properties.

• Post‑thaw viability means a lab tests whether cells survive after freezing and thawing. High viability is necessary for any chance at therapeutic effect.

• cGMP (current Good Manufacturing Practices) refer to manufacturing controls that ensure consistent product quality and safety — think of it as the clinical‑grade standard labs must meet.

• Not all products labeled “stem cell” actually contain living, functional cells. Some offerings on the market have little or no viable cells, or they’re processed in ways that reduce potential benefit.

• Accreditation (AABB, NMDP, AATB) and FDA registration are ways to check that a supplier follows accepted safety and quality processes. These reduce the risk of contamination, mislabeling, or ineffective products.

• Quality matters: If you’re preserving biological tissue now (cord blood, placental tissue), choose a bank that documents processing under cGMP, holds proper accreditations, and provides viability testing.

• Future access to treatments: Laws like SB‑1768 could increase clinical use of perinatal‑derived products in orthopedic and wound settings. Having properly banked, well‑documented tissue could expand future treatment options as the science advances.

• Cost and coverage: Broader legal pathways may speed up data collection and clinical experience, which could eventually lower costs and lead to insurance coverage for some regenerative treatments.

• The law removes some regulatory uncertainty for providers in Florida, potentially leading to more clinics offering perinatal‑derived biologics for allowed indications.

• It also raises the bar: suppliers and clinics must meet specific scientific and ethical standards, or face severe penalties. That should benefit patients by making it easier to identify reputable providers.

• Other states are watching. If similar laws spread, clinicians nationwide will need systems for evaluating suppliers and documenting informed consent.

• Ask for documentation: suppliers’ FDA registration status, accreditation (AABB/NMDP/AATB), cGMP compliance, and post‑thaw viability reports.

• Demand clear consent: make sure consent forms explain the product’s regulatory status, risks, and alternatives in plain language.

• For those considering banking perinatal tissue: select banks that follow clinical‑grade processing and long‑term storage standards.

• Clinicians should build relationships with reputable biologics suppliers and stay current on evolving laws and clinical evidence.

Florida’s SB‑1768 marks a shift toward clearer rules for some non‑FDA‑approved regenerative products. The law creates opportunities for innovation — but only if providers and suppliers meet strict quality, ethical, and transparency standards. For people thinking about stem cell banking, this change underscores the value of choosing accredited, cGMP‑compliant banks that provide verified viability data. That kind of careful preservation and documentation keeps more safe options open as regenerative medicine and longevity therapies mature.

Sources: Florida Senate Bill SB‑1768 (2025) and public analyses of the legislation; commentary from clinical providers and supply‑chain accreditation bodies (AABB, NMDP, AATB).