One day last March, Kristin Comella took to the podium at a conference sponsored by the Academy of Regenerative Practices to talk about the marvels of stem cell-based therapies and the challenges facing its pioneers.
"In fields where you're starting to do a new paradigm and bringing something forward that is a disrupter," she said, "there's always going to be naysayers." She cited several treatment advances achievable through stem cells, and attacked the Food and Drug Administration, which has set restrictive guidelines on the treatments she advocates.
"Why would the FDA regulate our own body?" she asked. "The fact that I have to say this out loud as a question is insane." She closed with an appeal for contributions for a "legal defense fund" to fight the FDA: "At this point it is on us to help educate the regulators."
It was a bravura performance by Comella, 41, who is the founder and president of the academy — crowd-pleasing, shot through with what sounded like serious science, delivered with the superficial credibility of a PhD from an unaccredited offshore university. Her pitch has made her a sought-after speaker at health industry conferences and gatherings of .longevity enthusiasts such as the annual Revolution against Aging and Death Festival, or RAADFest.
The therapies Comella talked about involve extracting fat from a patient's body by liposuction, isolating stem cells from the extracted fluid, and reinjecting those cells into the patient; the claim is that the stem cells will alleviate or cure a wide range of medical conditions from the inside. She maintains that the procedures — which typically cost thousands of dollars and typically aren't covered by insurance — shouldn't fall within the FDA's jurisdiction because they don't amount to manufacturing a drug.
The FDA disagrees. Its position is that these procedures aren't permitted without an FDA license. Indeed, what may not have been clear to Comella's audience is that the agency and other regulators are taking a closer look at the complex of stem cell entities she serves as chief scientific officer. They include a publicly traded biotech company, an affiliated treatment clinic in Florida and an investment partnership aiming to open 10 treatment clinics this year. Three such clinics already have opened in Florida, Dallas, and Southern California, according to a spokeswoman.
The biotech firm, Florida-based U.S. Stem Cell Inc., disclosed earlier this month that the Securities and Exchange Commission subpoenaed its financial records and other documents in connection with what the company says is a formal "fact-finding inquiry." U.S. Stem Cell declined to provide me with any further details of the probe, and the SEC declined to comment.
Regulatory scrutiny of this entire field is long overdue. The FDA has been signaling for nearly a year that it takes its responsibility seriously. FDA Commissioner Scott Gottlieb and agency official Peter Marks wrote last month in an article for the New England Journal of Medicine that giving patients these treatments risks "serious adverse events" and warned of the drawbacks of "propagating products with dubious clinical efficacy and possible risks."
U.S. Stem Cell is unusual among firms promoting scientifically unproven treatments in that it's publicly traded, albeit in the penny-stock market, where its shares have been selling recently for less than 6 cents. The firm describes itself as a company with "a research and development focus," although in 2017 it spent $6,644 on research and development and $4.4 million on marketing and other overhead, according to its annual report. The company recorded a net loss of about $3.5 million last year on revenue of $5.5 million.
The expansion of the company's clinic network is being done through an outside investment firm, General American Capital Partners, which hired Comella, U.S. Stem Cell's chief scientific officer, and Michael Tomas, its chief executive, to act in the same capacity in the rollout of American Stem Cell Centers of Excellence, the brand name of the proposed clinics. U.S. Stem Cell says the investors have committed to spend $2.5 million to open the 10 clinics.
GACP didn't respond to our request for comment. Keller Wortham, the Glendale physician identified by U.S. Stem Cell as the leader of its Southern California clinic, didn't respond to messages left at his home, medical office or his Hollywood agent's office. (He's appeared in several episodes of the TV show "Jane the Virgin.")
But it's plain that the expansion is aimed at getting a foothold in a market that could be worth billions — if the FDA or other regulators don't get in the way.
As it happens, the FDA hasn't merely proposed tighter regulations on stem cell nostrums generally — it has taken specific aim at U.S. Stem Cell Clinic. In a blistering warning letter last August, the agency cited the clinic for marketing stem cell products without FDA approval in a way that could be "putting patients at risk." The FDA said its inspectors had found 14 "significant objectionable conditions" at the clinic, including inadequate testing to ensure that the substances it was injecting into patients were free from contamination.
The FDA's investigation may have been prompted by a series of procedures in 2015 at the clinic reported in the New England Journal of Medicine in March 2017. The report concerned three elderly women suffering age-related macular degeneration, who the clinic treated by injecting liposuction-derived stem cells directly into their eyeballs. The procedure produced catastrophic damage to the patients' vision, including blindness in at least one case. Two of the patients later sued the clinic and settled with U.S. Stem Cell out of court.
A fourth patient, Jeannine Mallard, filed a lawsuit in December making similar allegations about an eye treatment she underwent at the clinic in February 2015. U.S. Stem Cell says her "allegations have not been corroborated." It says the clinic ceased treating macular degeneration in June 2015, "after adverse events were reported."
Comella told me by email in March that her firm's clinics have "shown positive results" in treating diabetes, multiple sclerosis, Parkinson's disease, brain trauma, chronic obstructive pulmonary disease (COPD), and even had produced "increased libido" in male patients. We've written in the past about the absence of scientific substantiation for such claims.
Facilities offering unproven stem cell treatments have proliferated nationwide by the hundreds. They exploit the desperation of patients who believe conventional medicine offers them no options for relief from intractable diseases and on the quasi-libertarian notion that regulators have no business telling people how to treat their own diseases.
The field has made common cause with purveyors of other "alternative" health treatments. Among the featured speakers at the Academy of Regenerative Practices' 2018 conference, for example, was Joseph Mercola, an antivaccine propagandist and purveyor of alternative nostrums who has received at least three warning letters from the FDA.
In 2016, Mercola settled a complaint from the Federal Trade Commission over his claim that the tanning beds he marketed could reduce cancer risk. He agreed to stop selling the devices permanently and to refund up to $5.3 million to customers who bought them. Comella appeared in a joint video with Mercola last year talking up the supposed benefits of stem cell treatments.
The field also strives to adopt a veneer of scientific legitimacy. Consider Comella's stem cell biology doctorate. It was issued by the Panama College of Cell Science, which identifies itself as a nonaccredited "virtual university." The Republic of Panama-based college offers a three-year online PhD at a price of $2,950 a year — $2,700 if paid in advance. The college calls its program "the hottest, most powerful biology graduate program in the world."
At the conclusion of the program, the college's website says, students receive a degree "beautifully created in color in the approximate size 8 x 10 inches, using various fancy font styles."
Comella told me through a spokeswoman that she "completed all required PhD coursework and research" at Florida International University before transferring to the Panama college.
The Panama program is a division of Blue Marble University, another virtual university based on the Caribbean island of Dominica. Both institutions were founded by Walter Drake, a onetime cancer researcher who preaches that treatments involving the reinjection of a patient's stem cells shouldn't be subject to clinical trials. Drake also holds a PhD in stem cell biology from the Panama college he himself founded.
Clinics offering untested stem cell therapies have been registering purported studies on clinicaltrials.gov, an online government listing of medical studies. This looks like another attempt to give scientifically questionable medical procedures the aura of serious research, by implying that the studies are government-approved. But the website doesn't screen studies for legitimacy before they're listed.
Albini and the Mallard lawsuit claim all four of U.S. Stem Cell Clinic's eye patients underwent their treatments after finding a research study on macular degeneration listed on the website by U.S. Stem Cell under its previous name, Bioheart. "They were under the impression that they had participated in a clinical trial," Albini told the FDA. In fact, the clinic enrolled no subjects in the study before withdrawing it in September 2015, after the four patients underwent their procedures.
That has drawn the interest of Sen. Charles E. Grassley (R-Iowa), who has asked the FDA for an update on its investigation of U.S. Stem Cell, and an explanation of whether the benefits of listing studies on the government site outweigh the risk that laypersons can be misled.
"The government needs to be careful not to create an avenue by which people can be scammed," Grassley told me by email.
Regulators nationwide should take heed, because a wave of clinics marketing unproven stem cell treatments is coming their way. Oversight agencies like the Medical Board of California should be proactive in the face of what could be a burgeoning public health crisis. The question they should be asking is obvious: Should licensed doctors be hawking unproven treatments?