Stem Cells in Florida: Everything You Need to Know to Incorporate These Revolutionary Treatments into Your Practice

Florida just changed the game for regenerative medicine.

With the passage of Florida Statutes §§ 458.3245 and 459.0127, effective July 1, 2025, physicians now have a clear, legal path to offering certain stem cell therapies outside of FDA approval, within strict clinical boundaries and ethical safeguards.

If you’re a licensed MD or DO practicing in Florida, here’s exactly what you need to know to incorporate stem cell and exosome-based therapies into your patient offerings - safely, ethically, and compliantly.

1. Table of Contents

   1. Understanding Florida's New Stem Cell Law

   2. How patients benefit: the clinical edge

   3. What’s the true value of these treatments?

   4. How to recognize reputable providers

   5. What to look for in a supplier

   6. What to avoid

   7. Meet BioRegen: Ethical innovation in regenerative care

   8. Ready to expand your practice?
      

1. Understanding Florida's New Stem Cell Law

The law permits only physicians (MDs or DOs) with active Florida licenses to deliver these therapies, and only within a defined scope: orthopedics, wound care, and pain management.

This includes:

• Patients with degenerative joint disease (like knee osteoarthritis)

• Non-healing diabetic ulcers or surgical wounds

• Chronic back, tendon, or musculoskeletal pain not responding to conservative treatment

Importantly, this law does not cover aesthetics, anti-aging, or systemic disease treatment. Patients seeking those services must either be referred to a clinical trial or treated under the federal Right-to-Try pathway. Knowing your boundaries is our legal and ethical duty.

2. Who Can Benefit from Stem Cell Therapies

Mesenchymal stem cells (MSCs) derived from umbilical cord tissue do more than “regenerate.” Their core advantage lies in cell signaling.

They release exosomes. These are tiny vesicles packed with growth factors, cytokines, and mRNA, that modulate inflammation, trigger tissue repair, and improve local immune responses.

Clinical effects often include:

• Reduced post-op recovery times by 40–60%

• Lower dependency on corticosteroids and opioids

• Reversal of microvascular damage in wound beds

• Cartilage density improvement in joints (as shown via MRI in clinical studies)

For patients caught in cycles of pain management or stalled healing, stem cell interventions may offer a next-step solution that restores function without escalating invasiveness.

3. What’s the True Value of These Treatments?

For patients, the value is life-changing, but only when applied correctly. Studies show patients can recovering from rotator cuff surgery in about half the time, or avoiding total knee replacement through biologic injection therapy.

For clinics, the value is strategic:

• You elevate your standard of care.

• You retain patients who might otherwise look to out-of-state or overseas solutions.

• You generate premium cash-pay revenue, with repeatable outcomes and lower risk compared to invasive surgeries.

But that value only holds if your therapies are sourced, stored, and administered within the strict framework of both science and law.

4. How to Recognize Reputable Providers

A qualified provider is more than a seller. They’re a verified partner in your care protocol.

Look for:

• Documentation of FDA Type II Master File (DMF) registration

• Post-thaw viability data per lot (not generic claims)

• Compliance with 21 CFR part 1271 for injectables and ISO 22716 for topicals

• Inclusion of a written informed consent template that aligns with Florida’s 5-point requirement

• Transparent storage, thawing, and delivery protocols

Anything less, and you’re not buying medicine, you’re buying legal risk.

5. What to Look for in a Supplier

Stem cells are not a commodity, they’re biologically active materials with strict sourcing and viability constraints.

At a minimum, demand:

• A Certificate of Analysis (COA) for every lot, not just once per year

• Proof of xeno-free culturing (no bovine or fetal calf serum)

• Cryo-preserved cells stored in -86° freezers, not dry shippers

• Triple testing: in-house, third-party lab, and post-thaw verification

• Detailed chain-of-custody documentation

Also ask about:

• Passage number (should be low for better efficacy)

• Population doubling (an indicator of cell age and potency)

• Cleanroom and GMP certification status

A serious supplier will provide all of this without hesitation.

6. What to Avoid

Florida’s law is clear: physicians may not use stem cells derived from aborted fetal tissue or operate outside the orthopedic-wound-pain scope. Violating these rules is not a fine—it’s a felony.

Red flags include:

• Stem cells sold without Rx designation

• No Certificate of Analysis or vague viability claims

• Providers marketing unapproved therapies directly to patients

• Topical exosomes used in microneedling depths over 0.5 mm without medical supervision

• Any mention of curing or treating systemic diseases outside Right-to-Try

If you see these practices, walk away. Your license and your patient’s safety are worth more.

7. Meet BioRegen: Ethical Innovation in Regenerative Care

BioRegen exists to set the bar, not follow it.

We produce:

• 25M UCT-MSC vials with 95–98% post-thaw viability

• 60 billion exosome vials grown in 3D cultures for exponential potency

• Topical 12B exosome vials for med spas with clear microneedling protocols

• A strict no-animal-serum, no-DMSO, xeno-free manufacturing process

All products are:

• FDA Type II DMF certified

• Verified through triple testing (in-house and two independent labs)

• Backed by live lot-specific COAs and viability reports

• Labeled per Florida law and delivered under strict cold-chain protocols

We also support you with:

• Clinical protocols

• Consent form templates

• Advertising guidance to stay 100% compliant

8. Ready to Expand Your Practice?

This isn’t just another service. It’s a movement toward high-integrity, biologic medicine.

If you’re a licensed Florida MD or DO practicing in one of the approved fields, you’re eligible to bring these therapies into your clinic now.

Let us verify your license. We’ll walk you through compliance. You’ll get instant access to the highest-quality regenerative products on the market.

Apply now or book a consult.

This is the future of healing, and you’re invited to lead it.