Stem cell clinics selling bogus, unregulated therapies to treat serious problems like cancer are a major problem in the US, and in November the Food and Drug Administration at long-last announced that such "unscrupulous" critics would bear the wrath of the federal government.
Instead of scaring them straight, the crack down seems to have emboldened at least a few clinics. In the Seattle area, a stem cell network is advertising its non-FDA approved offerings - and using a quote from the FDA announcement of the crack down to do it.
The ad, which ran in The Seattle Times as well as on the website for the clinic, Generation Stem Cell, quotes the beginning of FDA Commissioner Scott Gottlieb's statement, which expresses excitement about stem cells and regenerative medicine.
"We're at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine."
The announcement laid out a plan to make it easier for legitimate stem cell therapies to get to market, along with a plan to crack down on predatory clinics that operate outside of regulator bounds. Unsurprisingly, the ad leaves out this second bit: "Alongside all the promise, we've also seen products marketed that are dangerous and have harmed people."
Stem cells can be extracted from bone marrow, blood or fat, then coaxed into becoming many different types of cells. There is much excitement over their potential to repair diseased and damaged tissue.
The FDA has only approved a handful of stem cell therapies, but many more clinics offer stem cell-based procedures, some claiming that their work does not require regulatory approval. Part of plan laid out in November includes clarifying when the FDA has authority to regulate stem cell therapies. In August, the FDA brought action against two clinics that were performing liposuction to remove belly fat from patients, then injecting those cells back into the patients to treat different kinds of problems. In one potentially dangerous treatment being administered at one of the clinics, a treatment created from a live virus vaccine was being combined with stem cells and given to cancer patients with compromised immune systems. In March, a report in The New England Journal of Medicine described how one woman went blind and two others suffered permanent eye damage after another stem cell clinic injected stem cells into their eyes.
The Seattle-area clinic network in question is focused on treating joint pain using stem cells derived from body fat, known as adipose stem cells. "Stem Cell Replacement Therapy uses your body's own cells to naturally heal your body by regenerating new, healthy cells where injury or damage has occurred in the tissue," it claims. Its treatment protocols do not appear to have any kind of regulatory approval.
In response to an inquiry from Gizmodo, the FDA said it will be "scrutinizing this closely" to review claims made by the company and implementing any applicable regulations.
"To selectively quote the Commissioner and take his words out of context in this manner is irresponsible," the spokesperson said.
Gizmodo reached out to the clinic for comment, but did not receive a response.
Stem cell therapy offers great promise, especially when used in combination with other new technologies, like the gene editing technique CRISPR. Illegitimate stem cell clinics typically exploit lack of consumer understanding to sell them on bogus therapies, even listing them on clinicaltrials.gov to give them an air of legitimacy. At best, these therapies are a waste of money. At worst, as we've seen this year, they are incredibly dangerous.