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.

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.

Stem Cell Therapy in Pompano Beach, FL
Stem Cell Therapy in Pompano Beach, FL
  • 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.

Stem Cell Therapy in Pompano Beach, FL
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Ready to explore stem cell therapy under Florida’s new law?

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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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