MD on staff
Nexsis BioHealth
- IV Therapy
- Hyperbaric Oxygen Therapy (HBOT)
- Oxygen Therapy
- Arthritis Treatment
- Erectile Dysfunction (ED) Treatment
Miami, FL
Stem Cell Therapy clinics in Miami
Stem cell and cell-based therapy in Miami is a closely watched regulatory space. FDA-approved stem cell products (hematopoietic, select cord blood) are delivered at academic centers tied to Jackson Health System, Baptist Health, and University of Miami Health. The vast majority of cash-pay stem cell offerings, mesenchymal, adipose-derived, amniotic, exosomes, are not FDA approved. Demand reflects a large international, Latin American, and aesthetic-focused patient base.
The FDA has aggressively pursued clinics marketing unapproved stem cell products for orthopedic, neurologic, and autoimmune indications. Clinics in Miami, Florida operating in this space should be evaluated carefully for informed consent, product sourcing, and honest evidence framing. Florida Department of Health oversight of office-based surgery and stem cell claims shapes enforcement posture.
With stem cell clinics on Regenerated.com in Miami, patients can compare product type, FDA status, clinician credentials, and whether the clinic is enrolling in registered trials or operating outside them.
Karli Health
- PRP Therapy
- IV Therapy
- Hyperbaric Oxygen Therapy (HBOT)
- Oxygen Therapy
- Arthritis Treatment
GenLife Regenerative Medicine
- PRP Therapy
- Arthritis Treatment
- Hormone Replacement Therapy (HRT)
- TMJ Treatment
- Stem Cell Therapy
Florida Regen
- PRP Therapy
- Shockwave Therapy
- Ozone Therapy
- IV Therapy
- Laser Therapy (LLLT)
Organic Well
- Stem Cell Therapy
- NAD IV Therapy
- Vitamin IV Therapy
- IV Therapy
- IV Hydration
Regulatory context
A note on Florida's stem cell therapy rules.
Florida cellular therapy providers are governed by 21 CFR Part 1271. Section 361 applies to minimally manipulated HCT/Ps used for homologous use without premarket approval. Section 351 applies to products that are more than minimally manipulated, used non-homologously, or combined with another article, and these require an IND or BLA. Most stem cell, stromal vascular fraction, exosome, umbilical cord blood derived, and culture-expanded mesenchymal cell therapies marketed in Florida for orthopedic, neurologic, autoimmune, and longevity indications fall under Section 351 and lack FDA approval. Florida is a high-volume market, which has translated into elevated federal scrutiny.
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Florida Medical Practice Act, Florida Statutes Chapter 458 and Chapter 459
Establishes MD and DO licensure and disciplinary authority through the Florida Board of Medicine and Board of Osteopathic Medicine. -
Florida Pharmacy Act, Florida Statutes Chapter 465
Regulates compounding pharmacies in Florida and aligns with federal 503A and 503B standards relevant to biologic preparation. -
Florida Stem Cell Therapy Disclosure Rules, Florida Administrative Code Rule 64B8-9.0091 and 64B15-14.0091
Require physicians offering non-FDA-approved stem cell therapies to provide written disclosure of regulatory status to patients.
Florida has been a primary target of FDA enforcement. In US v US Stem Cell Inc (2019), a federal court in Florida granted a permanent injunction against a Sunrise-based clinic for marketing unapproved stem cell products derived from adipose tissue. The Eleventh Circuit upheld the injunction in 2021. The FDA has issued multiple warning letters to Florida clinics offering exosome and umbilical cord-derived therapies. The Florida Department of Health and the Boards of Medicine and Osteopathic Medicine have disciplined physicians for unprofessional conduct tied to misleading regenerative medicine marketing. The Florida Attorney General has pursued deceptive trade practice claims under FDUTPA against stem cell clinics.