Dr Tommy Rhee, CEO of RheeGen, outlines how FDA crackdowns have revealed dangerous and unethical tissue sourcing practices:
Two decades ago, regenerative medicine started out with an extraordinary scientific promise. In fact, early studies on mesenchymal stem cells (MSCs) gave the suggestion that we might be able to harness the innate repair mechanisms of the body to reduce inflammation, restore tissues that have been damaged and even accelerate healing. The idea that MSC’s could be delivered to an injured part of the body and behave like biological “first responders” captured the world’s attention immediately.
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The progression of science led researchers to discover something even more transformative, proving that the therapeutic effects of MSC’s were not only due to cells engrafting or turning into new tissue. Instead, it was discovered that healing came from the paracrine molecules that they secreted. These secretions were made up of extracellular vesicles, cytokines, growth factors, peptides, and other components of the MSC “secretome.” It is these signaling molecules that are now widely seen as the true drivers of regenerative repair.
This newfound understanding made it possible to open the door to a new class of treatments known as cell-free regenerative medicine. The treatments used these signaling molecules directly, rather than from the cells themselves. As more evidence to support this theory was collected, the world’s interest in regenerative treatments exploded across orthopedics, sports medicine, neurology, dermatology, and general wellness.
As such, the rapid commercialisation of stem cell therapy burst into the marketplace, and soon real science became entangled with misinformation, leading to uninformed markets and unsafe biologics.
It was this very excitement and exploitation that forced the US Food and Drug Administration (FDA) to take prompt action.
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By GlobalDataWhy FDA oversight became necessary
Stem cell therapy was being offered by more clinics across the world, and the FDA investigations showed that many of these clinics were using unapproved, mislabeled, or even contaminated human tissue products.
It was the FDA’s belief that several clinics were purchasing what was thought to be legitimate umbilical-cord- or placental-derived biologics, when in fact the products contained no viable cells or lacked any verified connection to the tissues they were advertised to come from [3][4].
To protect the public, the FDA strengthened its enforcement in areas such HCT/P 361 regulations, minimal manipulation standards, and homologous use requirements.
By enforcing such rules, the FDA’s intention was not to restrict regenerative innovation but rather to weed out unsafe and unethical players so the field could advance safely and responsibly.
The industry’s hidden problem: a corrupted supply chain
One of the most alarming issues investigated and uncovered by the FDA was the growing corruption happening within the regenerative biologics supply chain. FDA audits and warning letters repeatedly revealed concerns such as mislabelled or falsified tissue origins, improper or missing donor screening, and illegal tissue processing beyond minimal manipulation.
Moreover, there were several products that were being marketed as “umbilical stem cells” or “Wharton’s Jelly” that contained zero live cells, poor-quality tissue fragments, degraded proteins, or pooled donor fluids with no traceability. Shockingly, there were even cases where the tissue source listed on the vial did not match what was discovered during inspection.
These findings highlight the truth. There are patients and clinics who do not fully understand that several of the “stem cell” products sold in the US regenerative market are not what they claim to be.
FDA crackdowns are increasing – because they must
In recent years, the FDA has cracked down on their enforcement against manufacturers and clinics that are marketing unapproved regenerative products. Examples of this include warning letters to manufacturers who are illegally producing and distributing umbilical-cord-derived products without approval and shutdown orders for labs that do not have proper registration or are violating tissue-processing laws.
Such actions underline a critical point: FDA regulation is not the enemy of regenerative medicine. Unethical manufacturing is. And, without this oversight, products that are unsafe can enter the market, harming patients and eroding public trust.
As US labs close, unregulated clinics abroad are filling the void
As US regulators shut down unethical domestic labs, many suppliers are simply relocating to countries with less oversight. This has led to a surge of regenerative medicine “tourism” in destinations including Mexico and Colombia.
These regions often do not have mandates in areas such as equivalent HCT/P regulations, donor eligibility requirements, or sterility or potency testing.
To make things worse, reports and investigations showed that offshore clinics were using aborted foetal tissues, mixed donor fluids, animal-derived materials mislabelled as human, and unverified perinatal tissue products with unknown composition.
The most disturbing trend: products that are not what they claim
Some of the most disturbing trends in “stem cell therapy” were uncovered, and it was found that many products were not from umbilical or placental tissue or were animal tissue sold as human.
FDA audits and expert investigations found some tissue products marketed as “umbilical stem cells” to instead be vaginal secretion–derived fluids, pooled birth-tissue fluids, or biological waste products repackaged as regenerative injectables
There were also other audits that revealed that the tissue source did not match the product label.
Additionally, independent analyses have documented instances in which materials sold as human stem cells contained bovine, equine, or porcine biological materials.
The risks of these cross-species products were found to include prion disease, zoonotic infection, immune rejection, and complete therapeutic ineffectiveness.
Why clinics are being fooled too
The underlying issue is that these problems are rarely disclosed to patients, and more often than not, unknown even to the clinics that serve them. The reason for this is that clinics often rely on marketing materials and assurances from their distributors.
These distributors may misrepresent tissue origin, sterility, regulatory status, donor eligibility documentation, and inspection history.
The FDA holds clinics responsible even if the supplier misled them. Unfortunately, the problem is the fact that many practitioners are not aware that they may be injecting unverified or illegal tissue into their patients.
This is why transparency and documentation are essential.
The result: a crisis of trust in regenerative medicine
It is due to these unethical practices that, ethical researchers are often overshadowed, legitimate cell-free innovations are ignored, patients lose confidence in anything labelled “stem cells”, media coverage amplifies the worst examples, and insurers and medical boards adopt more restrictive positions.
The tragedy in this lies in the fact that regenerative medicine and the science backing it is strong. The issue lies in the lack of honesty, accountability, quality control, and transparency among certain manufacturers and clinics.
Possible solutions
Modern science shows that regeneration arises from bioactive signals, otherwise known as defined, cell-free technologies and not transplanted cells. These help to avoid risks such as contamination, immunogenic reactions, donor mismatch, and tumour formation.
Unlike donor-dependent tissue products, cell-free regenerative systems also allow consistent manufacturing, and this is the direction that responsible scientists believe the field must move towards.
There is an emerging area of research showing that certain plants produce bioactive molecules and extracellular vesicles (EVs) that are capable of influencing human healing pathways. These botanical signalers interact with cytokine signaling, inflammatory regulation, mitochondrial support, and tissue repair pathways.
Plant-derived vesicles and bioactive compounds represent a safer, ethically uncomplicated alternative. There is no donor variability, no disease transmission risk, and no human tissue concerns.
Because they are cell-free, botanical signalers can be delivered topically, non-invasively, without a medical procedure, directly to consumers, and at a much lower cost.
Understanding this shift could democratise regenerative care while at the same time help avoid the risks associated with injections of unverified biologics.
Protect yourself: three questions every patient should ask
Before receiving any regenerative injection, whether it is marketed as “stem cells,” “exosomes,” or “biologics”, patients are urged to ask several questions of their clinic.
Question 1: What FDA-registered lab manufactured this product? If the clinic cannot answer, do not proceed. Question 2: Can you provide the Donor Eligibility form, Certificate of Analysis, and lot number? These documents must match the vial.
Finally, when asked, a clinic should be to provide the lab’s most recent FDA inspection report or 483 letter. Transparency is non-negotiable.
If the clinic that you are in contact with cannot answer these questions, the product does not belong in your body.
