In this file photo, Austin surgeon Robert Ersek performs liposuction on himself to demonstrate how to harvest stem cells from body fat. (AP Photo/Austin American–Statesman, Larry Kolvoord)
Visitors to the website of
StemGenex, a La Jolla medical group, could be forgiven for thinking that the answer to their prayers is finally at hand. Pitched at sufferers of lung disease, Parkinson’s, autoimmune conditions such as multiple sclerosis and rheumatoid arthritis and even Alzheimer’s, the site offers treatments based on injecting patients with stem cells drawn from their own body fat.
StemGenex has made “great strides in the advancement of stem cell therapy,” the site says, “and is dedicated to providing patients access to safe and effective stem cell treatments.” StemGenex backs up its medical claims with brief video testimonials from patients.
Stem cells have become a medical buzzword. I see a lot of businesses using direct marketing to patients to take advantage of that.— UC Davis stem cell scientist Paul Knoepfler
To the stem cell research establishment, pitches like StemGenex’s warrant caution. According to the International Society for Stem Cell Research, an organization of academic and clinical stem cell researchers,
patients should be wary of “clinics that use persuasive language, including patient testimonials … to market their treatments”; of “expensive treatments that have not passed successfully through clinical trials” or are “offered without regulatory approval”; and of “clinics that offer the same cell treatment for a wide variety of conditions or diseases.”
StemGenex’s director of media and community relations, Jamie Schubert, told me that its “principal purpose is helping people with unmet clinical needs achieve optimum health and better quality of life,” and that it has “anecdotal feedback … from our patients that their symptoms have dramatically improved and their quality of life has substantially increased.”
But on its website, the group disavows any claim that “treatment using autologous stem cells [that is, cells drawn from the patient’s own body] are a cure for any condition, disease, or injury. ” It acknowledges that “stem cell therapy is not FDA approved and is not a cure for any medical condition,” and that U.S. health insurance companies won’t cover the procedure, which costs $14,900.
The proliferation of clinics nationwide offering stem cell therapies unnerves many researchers, who fear that unrealistic public expectations could undermine their own credibility. Patients with hard-to-treat conditions such as multiple sclerosis and Parkinson’s are easy marks who can be led to forgo established therapies in favor of unproven ones.
“Stem cell scientists include the best and the brightest doing great work, and I admire them,” says Janice Mulligan, a San Diego attorney currently assembling evidence for
a potential class-action lawsuit against unnamed stem cell clinics. “At the other end of the scale, there’s snake oil.”
Researchers Leigh Turner and Paul Knoepfler found 570 U.S. clinics marketing stem cell interventions, with "hot spots" (marked with blue stars) in Southern California, Phoenix, New York, San Antonio and Austin, Texas. (Turner and Knoepfler, Cell/Stem Cell)
In a survey this year of “stem cell tourism,” stem cell scientist Paul Knoepfler of UC Davis and bioethicist Leigh Turner of the University of Minnesota
identified 570 clinics around the U.S. offering stem cell “interventions.” Scores were concentrated in such “hotspots” as Beverly Hills, Phoenix and New York. Many were offering unproven therapies featuring the term “stem cell” as a marketing veneer.
“Stem cells have become a medical buzzword,” Knoepfler told me. “I see a lot of businesses using direct marketing to patients to take advantage of that.”
New study: Stem cell field is infected with hypeIn an article just published in Stem Cells Translational Medicine, Knoepfler
described his visit to one informational seminar sponsored by a clinic pitching a $5,999 stem cell treatment to about 30 attendees. Each was given a pack of forms to fill out, including a credit application. The spiel, he reported, featured personal anecdotes and “questionable medical claims” — including the assertion that “90% of patients had a 50% or better improvement.”
Sky-high price of new stem cell therapies is a growing concern“What got to me was that it felt like a hard sell,” Knoepfler says. “There were people in the audience suffering from various conditions that made them a fairly vulnerable population.”
The state of research into clinical stem cell treatments is “in its infancy,” says Knoepfler, a widely published scientist whose research has been supported with
a $2.2-million grant from the California stem cell program. “The research hasn’t gotten very far in a human context.”
The ability of stem cells derived from fat to rebuild damaged tissue in the human body by injection is an “attractive prospect” being pursued by numerous labs, he says, but no such therapy has shown its safety and efficacy in clinical trials, as the FDA requires before approving the treatment.
Nevertheless, hype about stem cell treatments is relentless, fed by self-interested clinics and press reports, especially those dealing with treatments undergone by sports stars. “These sorts of celebrity endorsements really feed the market for unproven treatments,” observes Timothy Caulfield, who studies pseudoscientific trends at the University of Alberta and is the author of “
Is Gwyneth Paltrow Wrong About Everything?” a 2016 book debunking celebrity-driven health claims. “They become very powerful anecdotes.”
Over the past few years, athletes reported to take stem cell injections for injuries include quarterback
Peyton Manning, tennis star
Rafael Nadal and Angels pitchers
Andrew Heaney and Garrett Richards. None of the treatments is standard and the results often ambiguous. (Heaney’s treatment already is
judged to have failed.)
The case of the vanishing seal of approval: On its website, StemGenex claimed accreditation by the AAAHC (top), until we asked about it. Then it disappeared (bottom). (StemGenex)
Medical regulators have trouble keeping up. The FDA has issued warning letters to distributors of topical creams claiming stem cell properties and
to at least one California clinic, the Irvine Stem Cell Treatment Center. The center and related clinics in New York and Miami were injecting fat-derived stem cells, purportedly to treat “autism, Parkinson’s disease, … multiple sclerosis (MS), cerebral palsy and amyotrophic lateral sclerosis,” or Lou Gehrig’s disease.
The agency judged the treatment to involve the illegal use of a drug, according to a December 2015 warning letter to the clinic’s owner, Dr. Thomas A. Gionis. He served a jail term in the 1990s in connection with an assault on his ex-wife, the daughter of John Wayne, according to
the Medical Board of California and reports in The Times. The Irvine and New York clinics may have been shut down. Gionis did not return a call to the Miami location.
The agency has scheduled
a two-day hearing next month on how to regulate treatments involving human cells and tissues. But that’s not quite the same as clamping down on the marketing of scientifically dubious therapies.
That brings us back to StemGenex. The medical group lists two physicians on its website, including Scott Sessions, a plastic surgeon. Sessions is currently facing an
accusation of negligence from the California Medical Board in connection with cosmetic surgery and other procedures he performed on two patients at an unrelated facility in 2011 and 2013. StemGenex declined to comment on the disciplinary case. Sessions could not be reached for comment.
StemGenex claimed on its website to be accredited by the Accreditation Assn. for Ambulatory Health Care, which provides seals of approval for outpatient surgical facilities. It’s not. StemGenex removed the references to the AAAHC from its website after we asked about them; the AAAHC also issued a cease-and-desist letter. StemGenex says the references were “outdated.”
Vivian Sjodin, 70, has had two $14,900 treatments at StemGenex, as she relates in this video posted on the medical group's website. But are they a long-term cure?
As for the “anecdotal feedback” on which StemGenex bases its claim of “dramatic improvement” in patients’ health, that can be equivocal, in part because patients can experience a placebo effect or only short-term improvements. Take the experience of Vivian Sjodin, 70, a Rapid City, S.D., real estate agent featured in a testimonial video on the website, who has been treated twice at StemGenex, paying $14,900 each time.
Sjodin, who had been a smoker for nearly 40 years, received what she says was a “devastating” diagnosis of chronic obstructive pulmonary disease, or COPD, in 2012. In April 2015, she got her first stem cell treatment at StemGenex, which she had found via the Internet.
At first the treatment seemed to produce a striking improvement, she recalls, enabling her to engage in activities that were closed to her until then. Within nine months, however, her health had declined again. “I could tell I needed another treatment,” she told me. That was done last June. She asked StemGenex if she might eventually need a third treatment. “They said they wouldn’t be surprised,” she says.
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