The attorneys general of Nebraska and Iowa filed lawsuits Thursday against Omaha-based stem cell therapy clinics and their operators alleging that they made deceptive and misleading claims in marketing unapproved treatments to older residents of the two states.
In separate but similar suits, Nebraska Attorney General Doug Peterson and Iowa Attorney General Tom Miller allege that the clinics targeted older residents with claims that the treatments could reverse aging and treat, cure or prevent a variety of medical conditions, including chronic obstructive pulmonary disease, neuropathy and Alzheimer’s disease.
Named in the lawsuits are related entities Regenerative Medicine and Anti-Aging Institutes of Omaha, Omaha Stem Cells LLC and Stem Cell Centers LLC, also known as Stem Cell Centers of Alaska LLC, and their owners, CEO Travis Autor and his wife, Emily Autor. The Iowa suit also names Mike Pavey, chief operating officer.
These events were labeled as educational seminars. But Miller and Peterson allege that the companies’ salespeople used high-pressure tactics to persuade Nebraskans and Iowans to buy unproven therapies costing thousands of dollars and not covered by insurance, Medicare or Medicaid. During that time, according to the attorneys general, the companies secured at least $2.2 million in sales in Nebraska. In Iowa, estimated sales totaled about $800,000.
Currently, the only stem cell-based products approved for use in the U.S. involve using cells from bone marrow, umbilical cord blood and blood to treat certain cancers and blood-related diseases.
The Food and Drug Administration wrote in a consumer advisory in December that stem cell therapies offer the potential to repair and restore cells and could possibly be used to treat many medical conditions and diseases. But for almost all of the products, it’s not yet known whether they have any benefit.
Miller said the law regarding health claims is strong. Such claims must be backed by science. The companies and their owners did not meet that mark. He and Peterson spoke in a joint video press conference Thursday.
“We take very seriously health claims in Iowa,” Miller said. “If someone is going to make a health claim in Iowa, they have to back it up.”
Miller said no Iowans appear to have been harmed by the therapies, other than a loss of money and having false hopes dashed.
But some Nebraskans may have been harmed.
Peterson’s lawsuit, filed in Douglas County District Court in Omaha, alleges that the companies purchased their stem cells products, including a product called exosomes, from EuCyt Laboratories LLC of Las Vegas.
The FDA warned EuCyt in a June 4 letter on 13 points. In the letter, the agency linked to a public safety notification it sent last December, advising that several Nebraskans had become ill after being treated with unapproved products marketed as containing exosomes.
In the June letter, the agency wrote:
Nebraska health officials also warned on the same day in December that some people in the state had become ill after receiving a product called exosomes that were derived from placentas.
State officials said at the time that fewer than five Nebraskans had become ill. All were recovering, they said, but some had been very sick. They also said that they could not provide additional details about the patients or the company that provided the products because of an ongoing health investigation.
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