Some falconry stem cells say they can treat almost anything. They can not

The mailings promised “Life without pain!” through stem cell or intravenous injections administered in the patient’s own home. The fascination was obvious: More than 20% of American adults suffer from chronic pain.

The flyers invited Iowans to free dinners throughout the state. Afterward, the salespeople traveled to potential customers’ homes for high-pressure presentations disguised as pre-showings, according to prosecutors. More than 250 people signed up, paying $3,200 to $20,000 each, for a total of $1.5 million. To do this, a nurse came to their homes to administer injections and serums filled with stem cells derived from umbilical cords.

Yet experts and regulators have alternately labeled these treatments as scams, frauds, or simply unproven. In some cases, studies have documented real harm.

Last fall, Iowa Attorney General processed two owners responsible for the mail in their state, naming a Minnesota man who hosts a Christian entrepreneurship podcast and his Florida business partner for allegedly deceiving consumers, many of them elderly.

In bringing the action, Iowa joined New York attorneys general, North DakotaGeorgia, Nebraska, Arkansas and Washington state, which have sued companies alleging they fraudulently promoted unproven stem cell treatments.

Stem cells have long fascinated researchers because of their ability to reproduce and, in some cases, transform into other types of cells. Because of this, they are believed to have the potential to treat many illnesses and injuries.

But the FDA has approved only a few of these therapies, and only for certain forms of blood cancer and immune system disorders. Stem cells are considered experimental for most uses, despite being marketed as treatments for everything from autism and emphysema to sports injuries.

The FDA has repeatedly warned Americans should be wary of companies selling unapproved, unproven, and expensive stem cell therapies, which have occasionally caused blindness, Bacterial infections and tumors.

In a 2020 warning, the agency expressed concern that patients are being misled about products that are “illegally marketed, have not been shown to be safe or effective, and in some cases may have significant safety issues.”

Dr. Jeffrey Goldberg, chairman of ophthalmology at Stanford University’s Byers Eye Institute, whose work has documented loss of vision in some patients treated with cells removed from the patients’ own bodies, processed and reinjected, lamented that people are “desperately willing to shell out large sums of money for therapies that are unproven and, in some cases, explicitly a kind of scam.” . ”

Since August 2017the FDA has issued about 30 warning letters about unproven treatments.

Experts including Dr. Paul Knoepfler, a stem cell researcher at the University of California, Davis, and Leigh Turner, a bioethicist at the University of California, Irvine, are among those who have warned that such federal action is too small to be regulated. The US industry which Turner estimated in 2021 surpassed 2,700 clinics.

Because states can seek substantial fines against rogue operators, Turner said their legal actions are promising.

“If you look at them collectively, they can, over time, start to have an impact,” he said.

The FDA provides training for attorneys general who pursue such cases. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said federal regulators partner with state authorities in a “shared mission.”

That puts people like Iowa Attorney General Brenna Bird on the front lines.

Last year, Bird opened the case over mailers that offered Iowans a pain-free life, naming as defendants the now-dissolved Biologics Health and Summit Partners Group, which operated under the name Summit Health Centers. The state also sued the companies’ owners: Rylee Meek of Prior Lake, Minnesota, and Scott Thomas of Thonotosassa, Florida.

Neither claims to have any medical training. However, during a series of free dinners in Iowa, attendees listened to presentations about how stem cells could apparently repair damage associated with back or joint pain. The demands arose despite a FDA Notice that no such product has been approved to treat any orthopedic condition.

One deposition featured a woman quoted as saying she had multiple sclerosis, fibromyalgia, degenerative joint problems and scoliosis. This implied that the treatment worked so well that she was able to stop using her walker and taking opioids. Prosecutors say this has left people believing that stem cells are effective in treating all of the conditions listed.

The company offered packages ranging from 5 million to 60 million cells to treat customers’ illnesses. The Iowa lawsuit described the practices as “scattered, for-profit experiments.”

Research has shown that dead cells are often injected, Knoepfler said.

The Iowa case is still in the discovery phase, with a trial scheduled for March 2025.

Meek and Thomas did not return multiple text and email messages from The Associated Press. Neither has his lawyer, Nathan Russell, although he has refuted many of the allegations in court filings, including that the promotional information was “misleading or misleading.” The lawsuit emphasized that Meek and Thomas always emphasized that they were not doctors.

Instead, Meek promoted himself as the “$100 Million Man” and touted his business prowess on his King’s Counsel podcast. His and Thomas’ book, “Influencer Influence in Sales: The Power of Persuasion with Neuro -linguistic Programming”, is described as a way of “getting people to think the way you want them to think, without them realizing it”.

Meek had previously reached an agreement with the North Dakota attorney general to resolve allegations that a company he ran sold insulation and energy conservation products without the proper license.

As for the stem cell business, Bird argued in the Iowa lawsuit that the companies downplayed safety concerns.

Sales material described the most concerning side effects as “flu-like symptoms” in a “very small percentage of patients.” It’s a claim that Meek and Thomas’ lawyer argued lacked context.

Complaints, which the business owners described as “rare,” surfaced, including from a man whose hip pain had not improved after undergoing a $5,845 treatment. His wife paid $2,650 for hers. Another person said they had “no improvement” after spending $16,580 to help with sciatic nerve pain and arthritis.

A nurse responded by saying that these patients could take longer to heal and that they should drink more water, the lawsuit said.

“The problem,” Knoepfler said, “is that people really get hurt and robbed.”