As of July 1, 2025, Florida physicians practicing orthopedics, wound care, or pain management can now legally incorporate certain non-FDA-approved stem cell therapies under state law. Here are five real cases that show just how impactful this law could be—for your practice and for your patients.
1. Knee Osteoarthritis: Restoring Mobility Without Surgery
For patients with knee osteoarthritis, the daily grind isn’t just metaphorical—it’s literal.
Pain, stiffness, and reduced mobility make every step a challenge. Most turn to corticosteroid injections or physical therapy, buying time until surgery becomes inevitable.
But in a 2023 randomized controlled trial, researchers explored an alternative: a single intra-articular injection of umbilical cord-derived mesenchymal stem cells (hUCT-MSCs).
No scalpel. No hospital stay. Just one outpatient procedure.
The goal was simple—stimulate the body’s own cartilage repair and reduce the chronic inflammation fueling pain. Over 12 months, participants reported significant decreases in pain scores, better joint mobility, and improved quality of life. MRI scans confirmed cartilage regeneration in a portion of the subjects.
This wasn’t a miracle. But it moved the needle from managing symptoms to restoring function.
Under Florida’s new stem cell law, orthopedic physicians can now legally offer this regenerative treatment in-clinic.
Source: Stem Cell Res Ther, 2023
2. Diabetic Foot Ulcers: A Last-Chance Therapy That Heals
For patients with chronic diabetic foot ulcers, time is the enemy.
Persistent wounds risk infection, hospitalization, and ultimately, limb loss. When skin grafts fail and antibiotics stall, many physicians are forced to recommend amputation.
But a 2022 study changed the prognosis.
Researchers applied allogeneic MSCs directly to ulcer margins. These weren’t skin substitutes—they were signaling cells. Their job was to reactivate angiogenesis, restore perfusion, and reignite the stalled wound healing cycle.
Over the course of treatment, patients showed significantly accelerated wound closure. In some cases, ulcers that had persisted for over a year healed within weeks.
Infection rates dropped. Amputation risk decreased. And most importantly, patients regained functional independence.
Today, under Florida law, wound care specialists can legally offer this same cell-based therapy to high-risk patients.
Source: Stem Cell Res Ther, 2022
3. Rotator Cuff Tears: Repair Without Surgery
Partial rotator cuff tears are a major source of chronic shoulder pain—especially in active adults over 40.
Traditional treatment involves physical therapy, corticosteroid injections, and eventually surgery. But for those caught in the middle—not bad enough for surgery, not better from rehab—a new option has emerged.
In a 2020 open-label study, researchers injected bone marrow–derived MSCs directly into the tear site using ultrasound guidance. The objective: support tissue remodeling, reduce inflammation, and enhance tendon fiber regeneration.
Patients began light movement therapy within a week. By six weeks, shoulder strength returned. By three months, MRI scans showed improved tendon thickness and less edema.
This was the first real evidence that biologics could reverse—not just mask—rotator cuff damage.
And now, thanks to Florida’s revised legislation, physicians in orthopedic practices can legally integrate this regenerative therapy without needing FDA approval.
Source: Osteoarthritis and Cartilage Open, 2020
4. Lumbar Disc Degeneration: Reclaiming the Spine Without Fusion
Lumbar disc degeneration is one of the most debilitating causes of back pain in middle-aged adults.
Steroid injections, physical therapy, and ablation provide limited relief. Fusion surgery may solve instability but at the cost of mobility. What if there was a third option?
A 2023 meta-analysis reviewed clinical trials involving MSC injections into degenerated discs. Across the studies, patients reported statistically significant improvements in pain, mobility, and function.
Imaging revealed a halt—or even reversal—of disc height loss in some cases, attributed to increased extracellular matrix production triggered by the cells.
No surgery. No permanent hardware. Just one guided biologic injection with systemic safety monitoring.
Thanks to Florida’s new law, pain specialists now have legal access to this regenerative technique for treating discogenic back pain.
Source: Frontiers in Bioengineering and Biotechnology, 2023
5. Plantar Fasciitis: Getting Patients Back on Their Feet
Chronic plantar fasciitis causes heel pain that can last years. Rest helps, but few patients can truly rest. Corticosteroids work—until they don’t. Surgery is invasive and inconsistent.
In 2023, researchers tested a novel therapy: injecting MSCs into the plantar fascia to reduce inflammation and accelerate tissue repair.
Patients experienced rapid improvements. Within weeks, ultrasound showed decreased plantar fascia thickness, improved blood flow, and reduced fluid accumulation. Pain scores dropped, and patients regained mobility.
This study offered hard proof that stem cells could reverse microtears and chronic inflammation at the root of plantar fasciitis.
And for Florida-based providers specializing in pain management, it’s now a legal, clinic-ready intervention.
Source: Biomedicines, 2023
Why BioRegen Stem Cells?
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Sourced from ethically donated umbilical cord tissue, with FDA Type II DMF certification
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3D-cultured for maximum therapeutic yield—up to 20x more growth factors than 2D systems
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Triple-tested: in-house, independent labs, and post-thaw viability reports for every lot
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Xeno-free and DMSO-free, reducing immunogenicity and toxicity risks
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Cryopreserved to -86°C, shipped under chain-of-custody conditions
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25 million UCT-MSC vials for clinical orthopedic and wound use
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60 billion exosome matrices for injection or microneedling (depth-limited by law)
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Comprehensive documentation for advertising compliance and informed consent
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Physician onboarding, clinical training, and protocol support
Ready to Expand Your Regenerative Practice?
The future of care is here. Let’s build it one cell at a time.

