December 16, 2025
Based on reporting by Ross Law and expert commentary from Dr. Tommy Rhee, CEO of RheeGen
For more than two decades, regenerative medicine has promised something extraordinary: the ability to harness the body’s own repair signals to reduce inflammation, restore damaged tissues, and accelerate healing. Early research into mesenchymal stem cells (MSCs) generated global excitement, with visions of cells acting as biological “first responders” at sites of injury.
However, as the science evolved, it became clear that the true therapeutic drivers were not the cells themselves, but the bioactive signals they release — cytokines, growth factors, extracellular vesicles, and peptides collectively known as the MSC secretome. This insight opened the door to cell-free regenerative medicine, a safer and more controlled scientific direction.
Unfortunately, rapid commercialization blurred the line between science and marketing — and that is where serious problems began.
FDA Crackdowns Expose a Troubling Reality
As regenerative treatments exploded in popularity across orthopedics, sports medicine, neurology, dermatology, and wellness, regulatory scrutiny increased. Investigations by the U.S. Food and Drug Administration revealed widespread and deeply concerning practices within the regenerative biologics supply chain.
These included:
- Unapproved and mislabelled human tissue products
- Inadequate or missing donor screening
- Illegal tissue processing beyond “minimal manipulation”
- Products advertised as umbilical or placental tissue that contained no viable cells
- Contaminated biologics stored or processed under unsafe conditions
In multiple cases, the tissue source listed on the vial did not match what inspectors discovered during audits.
The FDA’s enforcement of HCT/P 361 regulations, homologous use requirements, and minimal manipulation standards was not intended to stifle innovation — but to protect patients from unsafe and unethical products entering the market.
When “Human” Products Aren’t Human at All
Perhaps the most alarming discovery was that some products marketed as human stem cell therapies were not human in origin.
FDA audits and independent analyses documented instances where materials sold as “umbilical stem cells” or “Wharton’s Jelly” were found to be:
- Pooled birth-tissue fluids with no traceability
- Vaginal secretion–derived fluids
- Biological waste products repackaged as injectables
- Animal-derived materials mislabeled as human, including bovine, equine, and porcine components
Why This Matters
Cross-species biological materials carry real medical risks, including:
- Zoonotic infections
- Prion disease
- Immune rejection
- Severe inflammatory reactions
- Complete lack of therapeutic effect
Yet these risks are rarely disclosed to patients — and often not even known to the clinics administering the injections.
Medical Tourism and the Export of Risk
As unethical laboratories face shutdowns in the United States, many have simply relocated to countries with minimal oversight, fueling a surge in regenerative medicine tourism to destinations such as Mexico and Colombia.
Investigations have reported the use of:
- Unverified perinatal tissues
- Mixed donor fluids
- Aborted fetal tissues
- Animal-derived materials falsely labeled as human
- Products with no sterility, potency, or compositional testing
In many cases, these clinics operate without standards equivalent to FDA donor eligibility, tissue traceability, or contamination controls.
Why Even Reputable Clinics Get Fooled
Clinics often rely on distributor assurances and polished marketing materials. Documentation related to tissue origin, sterility, regulatory status, and donor screening may be misrepresented or entirely fabricated.
Crucially, the FDA holds clinics responsible — even when suppliers mislead them.
This means well-intentioned practitioners may unknowingly inject unverified, contaminated, or illegal biologics into patients.
The Result: A Crisis of Trust
The consequences are profound:
- Ethical researchers are overshadowed by bad actors
- Legitimate regenerative science is dismissed
- Patients lose confidence in anything labeled “stem cells”
- Media coverage amplifies the worst examples
- Insurers and medical boards respond with tighter restrictions
The tragedy is not that regenerative medicine failed — but that lack of transparency, quality control, and accountability damaged public trust.
A Safer Direction: Defined, Cell-Free Alternatives
Modern science increasingly supports cell-free regenerative approaches, which avoid the risks associated with donor-dependent tissues, including contamination, immunogenicity, and disease transmission.
Emerging research also points to plant-derived bioactive molecules and extracellular vesicles, which can influence human healing pathways without involving human or animal tissues.
These approaches offer:
- No donor variability
- No cross-species contamination risk
- No disease transmission
- Non-invasive delivery
- Ethical and regulatory simplicity
Protect Yourself: Three Questions Every Patient Must Ask
Before receiving any regenerative injection — whether marketed as “stem cells,” “exosomes,” or “biologics” — patients should ask:
- Which FDA-registered laboratory manufactured this product?
- Can you provide the Donor Eligibility form, Certificate of Analysis, and lot number — matching the vial?
- Can you share the lab’s most recent FDA inspection report or Form 483?
If a clinic cannot answer these questions clearly and transparently, the product does not belong in your body.
Regenerative medicine holds real promise – but contaminated, mislabelled, and animal-derived products masquerading as human biologics represent a serious and unacceptable risk. Transparency, regulatory compliance, and science-based innovation are not optional; they are the foundation of patient safety.