Stemming unproven stem cell therapy claims

Orange County, California - Old West nostrum sellers used to market treatments for a broad range of diseases with the slogan “Good for what ails ya.” California-based Regenerative Medical Group used a current buzzword in science – stem cell therapy – to peddle what they claimed were treatments for conditions as varied as cerebral palsy and autism to Parkinson’s disease, stroke, and macular degeneration. But according to the FTC, they didn’t have proof to back up their expansive promises. “What ails ya?”

For consumers struggling with serious diseases, the lawsuit demonstrates the FTC’s concern with “what fails ya” – in other words, unproven “cures” that lack scientific support.

Regenerative Medical complaint exhibits

Advertising online and through social media, the defendants, including owner Bryn Jarald Henderson, D.O., promoted stem cell treatments derived from the amniotic fluid of women who have given birth via C-section. Their marketing claims were – to say the least – dramatic. According to a promotional letter from Dr. Henderson, “Lives are being saved, the blind see, the crippled walk and the patients with heart, lung, kidney and nerve diseases can alter the course of their suffering with a simple therapy [that] lasts for years and impacts their lives NOW!”

The defendants’ ads also made express claims about specific intractable medical conditions:

  • “Stem Cell Treatments have been shown to improve sight in patients with Macular degeneration.”
  • “We can make blinded People see again!”
  • “We can reverse Autism symptoms.”
  • “Can stem cell therapy help patients with chronic kidney disease? Yes it can. It can make new cells that replace damaged cells and reverse chronic kidney disease symptoms.”
  • “Cure for Parkinson’s? The only Medical Group worldwide that treats Parkinson’s with amniotic Stem Cells!”
  • For stroke victims with damaged brain tissue, “Stem Cell treatment acts as a form of medical time machine, reversing the damage that has already been made.”

One of the company’s YouTube videos featured an 11-year-old girl with cerebral palsy who purportedly spoke “her first words” after receiving treatment from the defendants.

Regenerative Medical Group and Dr. Henderson charged consumers between $9,500 to $15,000 for an initial treatment with recommended “boosters” going for between $5,000 to $8,000. What’s more, they claimed that what they offered was comparable to or even better than conventional medical care.

That’s what the defendants said, but what’s the real story on stem cells? In fact, there are many different kinds of stem cells – amniotic stem cells are only one variety – and they vary widely in potency. According to the National Institutes of Health (NIH) website, “Much work remains to be done in the laboratory and the clinic to understand how to use these cells for cell-based therapies to treat disease.”

Furthermore, the vast majority of amniotic stem cell research has been conducted on animal models. According to the FTC, there are no human clinical studies showing that amniotic stem cell therapy treats any diseases in humans and certainly not the long list of conditions the defendants claimed to cure.

The proposed settlement requires the defendants to have human clinical testing to support future claims related to the treatment of any disease or health condition. Based on the defendants’ financial status, the $3.3 million judgment – which represents what patients paid for the treatments – will be partially suspended when the defendants turn over $525,000. That money will be returned to consumers. The company also has to send a letter about the lawsuit to their customers and others who have expressed an interest in their stem cell therapy treatments.

What does the FTC prescribe for misleading health representations? Here are some suggestions.

“Cure” claims command clinical confirmation.  Products that promise to treat or cure diseases need the support of human clinical testing. Don’t draft your ad copy until you have methodologically sound testing in hand that demonstrates statistically and clinically significant results. The FTC’s action against Regenerative Medical Group is the latest in a long line of cases challenging unproven treatments for autism, arthritis, macular degeneration, and other serious conditions. Claims like that are at the center of the enforcement radar screen and they’re likely to stay there.

Exercise caution when using in-the-headlines medical terms.  The phrase “stem cell treatment” covers a broad range of therapies – from promising research to flat-out fraud – and it may not be easy for consumers to make nuanced distinctions. Marketers shouldn’t add to the confusion by playing fast and loose with the facts. Don’t overstate the results consumers are likely to receive or falsely state or imply that your product is superior to other treatments.

Patients should study treatment options carefully.  People diagnosed with serious diseases can find a wealth of information online, but not every site is trustworthy. Before diving into the deep end of the internet, start your research with agencies like the NIH or FDA. Take stem cells therapies as an example. While encouraging scientists to continue their research, the FDA also has warned consumers about the dangers of questionable stem cell “treatments.”