Pioneering Stem Cell Therapy in Florida—Now Legally Available as of July 1, 2025
Under new state law,
licensed physicians can now offer ethically sourced, non-FDA-approved stem cell therapies for orthopedics, wound care, and pain management—under strict safeguards and transparency.
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Quick Overview of the New Law
Why This Matters
Florida’s legislature unanimously passed CS/CS/SB 1768 (House version: HB 1617), effective July 1, 2025, allowing physicians to administer non‑FDA-approved stem cell therapies for orthopedic, wound, or pain-related conditions .
Eligibility & Scope
Limited to licensed MDs/DOs in Florida
Treatments must relate specifically to orthopedics, wound care, or pain management .
Key Legal Requirements
& Patient Protections
Requirement
Details
Ethical Sourcing
Only adult stem cells (e.g., from cord blood or ethically sourced placental cells) are allowed; fetal‑derived sources are strictly banned .
Accredited Suppliers
Cells must come from facilities FDA-registered and accredited by AATB, AMAB, NMDP, WMDP, or similar.
CGMP Compliance
Collection and processing must follow Current Good Manufacturing Practices.
Post-Thaw Viability Testing
Each stem cell lot must include a post-thaw viability report delivered to the physician before use.
Advertising & Informed Consent
Public notices and patient contracts must state: “THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW…not yet approved by the U.S. FDA…”
Provider Qualifications
Only MDs/DOs are permitted to administer—NPs, med‑spas, DCs, etc., are not included.
Penalties for Non-Compliance
Doctors using fetal-derived cells, misleading marketing, or interstate unapproved products may face third-degree felony charges and board discipline.
What It Means for
Lighthouse Medical Center Patients
Access to Advanced Therapies
Now legally offering new regenerative treatments for joint injuries, chronic wounds, and pain—within a fully transparent, compliant framework.
Ethical Assurance
All treatments use adult/cord-derived cells from certified facilities—no embryonic or disputed sources.
Safety & Transparency
Detailed informed consent and viability reports ensure full patient awareness and confidence.
Expert Care Team
Our board-certified MDs lead treatment plans aligned with this law, keeping providers and patients well‑informed.
Frequently Asked Questions
Are these therapies FDA-approved?
No—state law permits their use, provided clear disclosure is made; federal FDA rules still apply, especially for interstate products.
Is there federal oversight?
Yes—interstate transfers or BLA violations remain under FDA jurisdiction.
Are treatments experimental?
They’re still considered investigational by the medical community, with potential benefits and risks. Our team discusses these thoroughly with you.
What am I expected to sign?
A written informed consent form that outlines the therapy’s unapproved status, anticipated outcome, risks, benefits, and alternative treatments.
Our Stem Cell Treatment Process
1.
Consultation & Evaluation
Confirm treatment suitability (orthopedic, wound, or pain-related).
2.
Source Verification
Our partners provide FDA‑registered, accredited, cGMP-compliant stem cells.
3.
Viability Reporting
You receive a detailed post-thaw viability report before treatment.
4.
Informed Consent Signing
We review disclosures, benefits, alternatives, and regenerate expectations.
5.
Treatment Administration
Carried out by our expert MD or DO team.
6.
Follow-Up & Monitoring
Track results and safety in compliance with state law.
Ready to explore stem cell therapy under Florida’s new law?
LEGAL DISCLAIMER:
All therapies remain non‑FDA-approved and are considered investigational. Lighthouse Medical follows all Florida CS/CS/SB 1768 regulations effective July 1, 2025, including sourcing, advertising, informed consent, and patient protections. State law doesn’t override federal jurisdiction over interstate transfers or non-compliant use.
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Thursday 9 am-6 pm
Friday 8 am-12 pm
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