On Friday August 25th, US Marshals seized five vials of a smallpox vaccine from a stem cell treatment center in California. The action was undertaken on behalf of the FDA, which followed up the seizure with a larger announcement targeting the "unscrupulous clinics" selling unproven stem cell treatments that have rapidly arisen across the United States in recent years.
The unconventional smallpox "treatment" was being delivered by a company called StemImmune. The FDA alleges that the smallpox vaccine treatment was discovered after inspecting two California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. The vaccine was apparently being combined with adult stem cells derived from a patient's body fat and this combined product was then administered to a patient either intravenously or injected directly into the tumors.
Not only does this strange treatment have no clinical backing, but the FDA noted "serious concerns" as to how the company obtained this vaccine in the first place.
"The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work," says Scott Gottlieb, FDA Commissioner. "I especially won't allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse."
Dr. Mark Berman of the Cell Surgical Network, who works with the California Stem Cell Treatment Centers, fired back angrily at the FDA claiming Gottlieb's comments were "disparaging and misrepresentative."
The statement went on to claim that StemImmune's work involved, saying "many top national and international doctors and scientists are participating in this study, including our nation's own Department of Defense."
A study was published in 2016 documenting the rapid rise of commercial stem cell treatment centers in the US. Paul Knoepfler and Leigh Turner's research paper was published in the journal, Cell Stem Cell, and it chronicled a startling 351 businesses marketing unapproved stem cell interventions across 570 clinics.
This frightening study revealed a burgeoning marketplace in the US, replacing the traditional trend of "medical tourism." Exploiting potential loopholes in the regulatory system, these clinics were offering unproven stem cell treatments for just about every disease you can think of.
"Brakes ought to exist in a marketplace like this, but where are the brakes? Where are the regulatory bodies?" says Leigh Turner, co-author of the study. "And how did this entire industry come into being in a country where stem cell-based interventions and the medical devices that produce them are supposed to be regulated by the FDA?"
These stem cell clinics seem to be operating inside a grey area whereby their treatments are not exactly classifiable under general FDA regulations. Many of these clinics simply extract stem cells from a patient's adipose tissue, subject those cells to minimal manipulation, and then implant them back into the same patient. This allows the procedure to be classified under a surgical procedure exemption meaning it doesn't need regulatory approval. Essentially it is not a "drug" or "medical" procedure, but instead just a straightforward "surgical" procedure.
The FDA has recently looked to address this loophole. Since 2015 the regulatory body has been working on reclassifying the way it views the repurposing of a patient's own tissue. Draft guidelines, not yet passed into law, are designed to classify these stem cell treatments as "drugs," meaning any treatment will need to undergo a stringent approval process.
Alongside the more dramatic smallpox incident, the FDA recently reset the battle lines with stem cell clinics. One company, called US Stem Cell Clinic (USSC), was delivered an expansive warning letter from the FDA arguing that the repurposing of adipose tissue in this context must be considered a drug.
The company responded by claiming the procedure is exempt from regulation, "because the procedures practiced at USSC do not involve more than 'minimal manipulation'." It seems the fundamental questions being argued here are how much manipulation of the tissue is actually taking place and for what is the claimed function of the resulting implantation?
The latest FDA announcement is drawing a line in the sand. Stem cell clinics delivering unproven treatments are on notice. It's yet to be seen actually how far the FDA will be able to go in legally moving on some of these clinics, but a new framework, set to clarify the regulatory processes surrounding these new treatments, will be delivered soon.