On the first Saturday of March, Kristin Comella put on a white doctor’s coat and took the stage at the fourth annual conference for the Academy of Regenerative Practices. The founder and president of the academy, Comella also oversees an expanding empire of stem cell clinics that promise patients cures for most anything that ails them. None of those treatments—for everything from diabetes and asthma to multiple sclerosis and arthritis—have been approved by the US Food and Drug Administration.
The procedure—which costs a few thousand dollars—is always pretty much the same, regardless of its purported target. It involves sucking out some of a patient’s fat tissue with a liposuction needle, isolating the stem cells within, and reinjecting them into the patient’s body. The simplicity of the procedure is why people like Comella say it’s “insane” for the FDA to try to regulate stem cells.
So it was surprising when she announced onstage that her firm, US Stem Cell, had recently begun developing a radically new kind of treatment—this time, for cancer.
“Your stem cells are antigen-presenting cells,” Cormella told the audience, in a Facebook live video the company posted of the event. “We can make them express a protein from your specific cancer. So, it’s an individualized cancer vaccine, if you will.” US Stem Cell, a publicly traded firm that sells stem cell separation kits and operates one of the largest networks of clinics in the country, achieved this with something called an “electroporation protocol,” she said.
Electroporation is essentially zapping cells with electricity—a microbiology technique used to get drugs, proteins, or, most commonly, DNA into cells. “When I hear electroporation, that’s equal to genetic modification,” says Paul Knoepfler, a stem cell researcher at UC Davis. “That’s what we do when we want cells to permanently express a protein.”
Knoepfler writes a blog about stem cells, and that’s where he surfaced the video on May 9, after an acquaintance tipped him off. He’s sort of a watchdog for the industry. Since 2011, he’s tracked the proliferation of unregulated stem cell clinics and followed US Stem Cell’s cavalier approach to experimenting on its patients, sometimes to disastrous effect. In 2015, one of its clinics injected liposuction-derived stem cells directly into the eyeballs of three elderly women suffering from age-related macular degeneration. All three went blind, two sued, and US Stem Cell settled out of court.
But this, he says, might be the most dangerous thing he’s seen yet. “If my assumption is correct that they’re introducing DNA, this is up near the top of the riskiest things I’ve ever heard a stem cell clinic doing,” he says. “The big worry here is giving cancer patients another cancer, or a dangerous immune response.”
US Stem Cell did not respond to WIRED’s questions about the procedure, so it’s still unclear if it does indeed involve genetic modification and whether any patients have actually been treated with it. In the video Comella only described it as one of the company’s “current protocols.”
What we do know is that the approach sounds similar to a powerful new class of anti-cancer medicines known as CAR-T therapies. They involve extracting a patient’s immune cells and genetically rewiring them to more effectively recognize and attack cancerous cells in the body. The FDA approved the first CAR-T, Kymriah, in late 2017 after scrutinizing years of data from animal studies and human clinical trials. Novartis claims it spent $1 billion to get the treatment to market.
Compare that with the $6,664 US Stem Cell reported having spent last year on research and development. The company—formerly named Bioheart—has nine clinical trials listed on the national registry ClinicalTrials.gov, none of which are actively recruiting and none of which are for cancer treatments. Though listed as the lead investigator on some of the trials, Comella isn’t a medical doctor. She received a three-year online PhD in stem cell biology from the Panama College of Cell Science—a non-accredited virtual university founded by stem cell evangelist Walter Drake, according to reporting by the LA Times. And she’s not afraid to spar with the federal government.
Last August the FDA sent a warning letter to US Stem Cell and to Comella, specifically, for “significant deviations” from good practices. And after Comella responded with a letter of her own, denying FDA has any jurisdiction to regulate her company’s activities, the agency followed up with a lawsuit.
On May 9, the FDA along with the Department of Justice filed a complaint seeking a permanent injunction against US Stem Cell and Comella, accusing them of endangering patient safety and failing to meet manufacturing standards for cell therapies. The federal officials also filed a similar lawsuit against another clinic—California Stem Cell Treatment Center—which was involved in giving patients an experimental cancer treatment made from a mix of stem cells and a smallpox vaccine inappropriately acquired from a Centers for Disease Control and Prevention stockpile under the auspices of research. When officials found out they were being administered to patients, US marshals raided the clinic and seized the remaining vials.
Both California Stem Cell Treatment Center and US Stem Cell said in public statements they plan to fight the injunctions, the most aggressive volley yet in the conflict surrounding direct-to-consumer stem cell treatments. At the heart of the clash is the phrase “minimally manipulated,” which the FDA uses to exempt therapies like bone marrow transplants. Both clinics will likely argue in court that their cell-based treatments fit that description. But Comella’s recent statements at the conference could undermine this claim. Electroporation is a tool designed explicitly for cellular manipulation, and there’s nothing minimal about it.