Stem Cell Centers Gets Sued for Consumer Fraud
Stem Cell Centers is one of the many nurse staffed clinics that make claims about antiaging and treating a panoply of incurable diseases with “stem cells” and exosomes. The company is now being charged in Iowa and Nebraska with consumer fraud. Let’s dig in.
Stem Cell Centers
This company is owned primarily by a chiropractor who lost his license to practice in 2009 and changed his last name from Broughton to Autor (1). At the time, Travis Broughton was accused by the Washington State chiropractic board of double-billing, having sex with a patient, and smoking marijuana during lunch breaks. He set up a new chiropractic practice in Idaho in 2014. By 2015 he had changed the name of the practice to “Stem Cell Centers”. By 2018 he had seven clinics from Florida to Arizona.
I’ve blogged on the “Stem Cell Centers” clinic chain before. They are generally staffed by nurse practitioners with about half or less of the training of physician specialists. The clinic injects “stem cells” from umbilical cords and has recently added “exosomes”. They aggressively recruit patients at seminars where professional salespeople apply heavy-handed sales tactics.
Dead Stem Cells
We’ve known for a while that the umbilical cord and amniotic products that clinics like “Stem Cell Centers” use, while sold to the elderly as containing plentiful young and vital stem cells, are actually dead tissue. This has been shown now in multiple studies done in multiple labs and universities across the country (3-5).
This clinic chain purchased it’s “stem cells” and exosomes from Eucyt labs, which recently received an FDA Warning Letter. The FDA wrote that the company’s claims of selling a stem cell product (whether or not that was true) made its product a drug that required an FDA approval that the company did not have. The company also had many manufacturing violations like not screening donors properly and sterility breaches. For example, they had 152 sterility failures that needed to be investigated by the company but were not.
In fact, it’s believed that Eucyt was behind the FDA Warning Notice on exosomes published back in December of last year. In that warning, the FDA stated that several patients in Nebraska had been sickened by exosome products. This is where the attorney generals for the state of Iowa and Nebraska come in…
The Consumer Fraud Complaint
This week the attorney general of the state of Iowa, Thomas Miller, filed suit against Autor and Stem Cell Centers. In addition, the state of Nebraska also filed a similar complaint. Named in the lawsuit were the Regenerative Medicine and Anti-aging Institutes of Omaha, Omaha Stem Cells, and Stem Cell Centers, LLC. The claim states that Autor’s Nebraska clinic targeted the elderly with almost 100 seminars. For example, last summer, the defendants held two seminars a day for a week in various locations throughout Iowa. The complaint stated that instead of educational seminars, these events were instead more like high-pressure sales events that offered high-interest rate financing plans for those who couldn’t afford the treatments.
Some interesting picadillo’s from the Iowa complaint:
- Defendants recognized they could impart a semblance of medical legitimacy to their seminars and increase sales of their unproven treatments by quoting from and citing to scientific studies throughout the seminar presentation. Indeed, as Defendant Travis Autor once explained to his sales staff during a company training session: “The more of these studies I can quote and stuff – it gives me more authority . . . that I know what I’m talking about.”
- Defendants’ seminars were laden with high-pressure sales techniques focused on, among other things, selling bigger, more expensive stem cell and exosome
packages to consumers who did not need them. They included “pre-suasion” and “psychology of sales” rhetorical tactics that the Defendants believed predisposed seminar attendees to buy their products.
- One of Defendants’ television commercials that aired in Iowa told viewers that “Stem cell therapy has the ability to reverse your COPD…”
Bait and Switch Studies
The complaint also discusses that when confronted about the claim that “stem cells” could reverse COPD, Mr. Autor sent an unpublished “study” with seven COPD patients. The study, of course, used a different therapy (adipose stromal vascular fraction — not the dead umbilical cord stem cell product) used by “Stem Cell Centers”. The trial was also tiny and of poor quality.
From the complaint:
“49. Defendants claimed their stem cell therapy and exosome therapy could reverse the effects of growing older.
50. For example, in the “anti-aging” segment of their seminar presentation, Defendants asked attendees: “Anyone Wish They Could Turn Back The Hands Of Time?” On the next slide, they reassured consumers, “Stem Cell Therapy Can Do Just That.”
Stem Cell Centers also discussed in its seminars that research showed that its therapy could reverse aging by as much as three years. When asked to substantiate that and other claims, Autor and the company claimed that a fragility study that used culture-expanded bone marrow stem cells proved the claim (2). This treatment obviously has nothing to do with the dead umbilical cord tissue the company was injecting IV. This pilot study seemed to help the frail elderly improve their function, but the authors never claimed that the therapy reversed aging by up to 3 years.
What Can You Learn Here?
Clinics like this often use research studies on their websites and in presentations that have little to do with what they’re offering. Despite this, they often claim that these are “proof” that what they do is effective. They don’t perform any research of their own. In a real clinic using regenerative medicine, you should expect that the clinic uses the same methods as any research they show you.
From the complaint:
“82. Defendants made unfounded claims that bigger and more expensive stem cell and exosome packages were more effective to stop or slow down diseases and medical conditions.
83. For example, on a consumer “sell sheet” highlighting COPD Defendants described the largest option of 6 treatment doses or 24 units (priced at $15,997 or $16,997 at different times) as follows: “The bad news is this is the most expensive option but the good news is it should be the most effective. Six treatments will give you the greatest chance at restoring your lung function by ‘turning off’ or substantially slowing the debilitating progression.” Defendants made very similar claims that more doses of stem cells or exosomes were “most effective” to slow down or stop spine and disc pain, osteoarthritis, and neuropathy in sell sheets focused on those conditions.”
In fact, there was no data on the dead umbilical cord product used by the company that showed that higher doses conveyed any additional benefits. There was also no research that the dead umbilical cord tissue being injected by the company could help any condition.
In an actual medical clinic, you’re a candidate or not or a good candidate or a poor candidate based on your medical condition. Hence, you can’t sell somebody a treatment until there is a medical evaluation and examination. In addition, the dose of that therapy is also determined by the severity or type of medical condition you have, so you can’t sell a dose at a high-pressure sales event.
From the complaint:
“89. Defendants targeted consumers who did not have health problems with unfounded claims that stem cells or exosomes could prevent or allay undetected medical conditions.
b. As mentioned in Paragraph 71(b), Defendants told consumers that stem cells or exosomes could “break down plaquing BEFORE you get symptoms [of Alzheimer’s disease], possibly delaying or even preventing this disease.
91. Defendants trained their employees and sales representatives to sell treatments to people without medical problems. For example, in a training session for seminar
speakers on how to present Defendants’ slideshow, Defendant Travis Autor
explained that: I am talking in this slide because I want people to be aware that they
need to buy a 24-unit treatment.42 Just because you don’t have symptoms, does not mean you don’t have problems. And I’ll say, I will look around the room and say …‘every single person in this room knows one or two people who have died suddenly from a heart attack that didn’t even know they had heart problems, correct?’
Everybody [is] like – ‘uh huh, yeah’”
If you’re a patient, then the takehome is obvious. Any clinic offering you “stem cells” from birth tissues is lying. Any clinic seminar that feels like a high-pressure sales event and is selling you a medical treatment BEFORE a medical evaluation of candidacy is a scam. Any research study you see needs to have tested the same exact treatment as the one you’re getting.
If you’re a medical provider, read the complaint carefully. These are the questions I would ask myself based on the book they’re throwing at this clinic chain:
- If you use birth tissues and claim you’re offering stem cells – you’re toast.
- If you use research studies on your website to promote the therapy you offer that don’t EXACTLY match the therapy you deliver, you have problems.
- Those research studies had better provide clear and convincing evidence consistent with the standard of care for other alternative solutions the patient could receive instead of your therapy.
- There had better be research supporting the “dose” of cells that you use. Meaning not measuring the dose or knowing which dose works based on research on that therapy is a problem.
- Claiming that stem cells or exosomes can cure aging to make someone younger is foolish.
- Offering patients to pre-purchase a therapy at a seminar without a physical exam and diagnosis is below the standard of care.
- Treating patients who have no medical conditions on the idea that stem cells will magically fix we don’t know is wrong speaks for itself.
The upshot? IMHO this clinic chain and Mr. Autor are going to have big troubles defending this claim. That begins with offering dead umbilical cord cells and convincing consumers that these were live stem cells!
- Associated Press. Stem cell therapy clinics are big business in Spokane area, but are desperate patients being sold snake oil? https://apnews.com/cd0088dffda1452c99362c2f84071aaa Accessed 7/16/20
- Bryon A. Tompkins et al., Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial, 72 JS. GERONTOLOGY, 1513, 1513-1522 (2017).
- Berger D, Lyons N, Steinmetz, N. In Vitro Evaluation of Injectable, Placental Tissue-Derived Products for Interventional Orthopedics. Interventional Orthopedics Foundation Annual Meeting. Denver, 2015. https://interventionalorthopedics.org/wp-content/uploads/2017/08/AmnioProducts-Poster.pdf
- Becktell L, Matuska A, Hon S, Delco M, Cole B, Fortier L. Proteomic analysis and cell viability of nine amnion-derived biologics. Orthopedic Research Society Annual Meeting, New Orleans, 2018. https://app.box.com/s/vcx7uw17gupg9ki06i57lno1tbjmzwaf
- Panero, A, Hirahara, A., Andersen, W, Rothenberg J, Fierro, F. Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. The American Journal of Sports Medicine, 2019 47(5), 1230–1235. https://doi.org/10.1177/0363546519829034