Iowa Attorney General Tom Miller is suing an Omaha-based stem cell therapy center for allegedly targeting older Iowans with claims to reverse aging and treat, cure or prevent a variety of medical conditions, including chronic obstructive pulmonary disease, neuropathy, and Alzheimer’s disease.
The lawsuit filed Thursday in Polk County District Court alleges that Regenerative Medicine and Anti-Aging Institutes of Omaha made deceptive and misleading claims in advertisements and more than 90 live events that were held throughout Iowa from April 2018 to September 2019. Miller alleges the company’s salespeople used high-pressure tactics to persuade possibly hundreds of Iowans to buy unproven procedures that cost from $1,400 to more than $27,000 and are not covered by health insurance.
The U.S. Food and Drug Administration has approved stem cell therapy to treat patients with disorders that affect the hematopoietic system, which is involved in the production of blood. Stem cell therapy is still in beginning stages of research as applied to various other medical problems and has not been scientifically established as safe and effective.
“Stem cells hold great potential to treat or even cure diseases, but some providers are exploiting that promise to make misleading and unfounded claims,” Miller said. “The defendants are an example of the ‘unscrupulous providers’ that the FDA and others have warned consumers about.”
In addition to Regenerative Medicine and Anti-Aging Institutes of Omaha, the defendants in the lawsuit are related entities Omaha Stem Cells LLC and Stem Cell Centers of Anchorage, Alaska; and their owners CEO Travis Autor, Emily Autor and COO Mike Pavey.
Miller’s office is seeking an injunction against the defendants, consumer restitution, and civil penalties of up to $40,000 for each violation of the Consumer Fraud Act and $5,000 for each violation of the Older Iowans Law.
Nebraska Attorney General Doug Peterson filed a similar lawsuit Thursday against the stem cell therapy providers.
Miller’s lawsuit alleges that the defendants used newspaper, television and direct-mail advertisements to promote unproven treatments involving stem cells and exosomes, which are excreted by stem cells.
“Today’s regenerative medicine offers a revolutionary treatment that helps to heal your injured tissue,” some ads claimed. “If you suffer from injured or degenerative conditions in your back, knees, hips, shoulders or have arthritic joints or suffer from neuropathy or respiratory diseases like COPD, Stem Cell Therapy can help get you out of pain and discomfort!”
One television commercial that aired in Iowa told viewers that “Stem cell therapy has the ability to reverse your COPD.”
The ads typically invited consumers to attend in-person “educational seminars” at local hotels. “The events were extended sales pitches carefully designed to part all older Iowans who attended from as much of their money as possible,” the lawsuit alleges. The pitches included high interest-rate financing options. The businesses distributed pamphlets ― including these promoting anti-aging and COPD treatments ― that made unfounded claims.
The seminars featured presentations that made unsubstantiated claims. One slide, for example, stated “Anti-Aging: Mesenchymal Stem Cell infusions turned back the hands of Father Time about three years! Would you like to get back three years?”
Presenters cited several scientific studies, which the lawsuit contends did not support defendants’ claims, were often limited in application, and taken out of context.
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,” the lawsuit alleges.
Autor also acknowledged in training sessions that most or all of his customers were older people. Defendants sent virtually all of their direct mail advertisements to consumers age 60 and older, the lawsuit alleges.
The lawsuit alleges that defendants trained their employees and sales representatives to sell treatments to people without medical problems and to “upsell” them on higher doses of stem cells and more expensive treatments.
“Once somebody has, you know, agreed to 9,000 or to 15,000 (dollars), getting another 1,000 is easy. It really is,” Autor told employees. “So, the psychology of sales: Once a person commits to a large purchase, they get a huge endorphin rush in the pleasure spot of our brain, called the brain reward cascade system. And the endorphins are released, and we are like ‘ah…’ … Um, so, when a patient gets to 15,000 dollars and they get that rush, we’re gonna offer them a second ability to have that rush again.”
Travis Autor has operated stem cell centers in several states, including Arizona and Idaho. He lost his chiropractor license in 2009 in a settlement with the state of Washington over allegations of double-billing, having sex with a patient and smoking marijuana during lunch breaks at his business, according to a news report.
Stem cell treatments: Consider these cautions
When it comes to stem cell treatments, the U.S. Food and Drug Administration warns: “Don’t believe the hype.”
Stem cell therapies may offer the potential to treat many diseases or conditions, the FDA says, but the agency warns that some treatments are illegal and potentially harmful.
In December, the FDA issued a public safety notification after multiple patients in Nebraska suffered “serious adverse events” after being treated with unapproved products marketed as containing exosomes. There are no FDA-approved exosome products for any medical condition. Exosomes are not stem cells but are excreted from cells.
If you are considering stem cell treatments, the agency advises the following:
- Ask if the FDA has reviewed the treatment. Determine whether the treatment is FDA approved or being studied under an Investigational New Drug Application, which is a clinical investigation plan submitted and allowed to proceed by the FDA. Ask your health care provider to confirm this information — even if the stem cells are your own.
- Request the facts and ask questions if you don’t understand. Make sure you understand the entire process and known risks before you sign a consent form.