The attorneys general of Nebraska and Iowa filed lawsuits Thursday against Omaha-based stem cell therapy clinics and their owners 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 Institute 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.
The lawsuits allege that the clinics made deceptive and misleading claims in advertisements and in at least 84 live events in Nebraska and more than 90 in Iowa from April 2018 to September 2019.
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 that are not covered by insurance, Medicare or Medicaid, meaning consumers most likely paid out of pocket. The companies also offered financing through a third party. 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. However, clinics marketing such products have proliferated across the country in recent years. Because of a number of reported ill effects around the country related to unapproved products, the FDA has increased its oversight and enforcement of the industry.
Miller said the law regarding health claims is strong. Health claims must be backed by science. The companies and their owners did not meet that mark, he said. 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 losing money and having false hopes dashed.
But some Nebraskans may have been sickened.
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 based on a November 2019 inspection, a number of them involving concerns about sterility. 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.
The agency wrote:
“With regard to your unapproved exosome product XOsomes™, we direct your attention to FDA’s Public Safety Notification on Exosome Products, available at fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products. FDA issued that public safety notification following multiple reports of serious adverse events experienced by patients who were treated with XOsomes™.”
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.
EuCyt did not return emails seeking comment.
Peterson said he would not rule out adding defendants to the case. He and Miller encouraged Nebraska and Iowa residents to come forward if they have information about the companies and their activities. Nebraskans can call 1-800-727-6432 or go to https://protectthegoodlife.nebraska.gov/contact-us.
“It’s important for Nebraskans to come forward if they have information so we can successfully get restitution at the end of this lawsuit,” Peterson said.
Miller said he believes the amount spent by Iowans will grow as attorneys continue to develop evidence in the case.
Both lawsuits seek an injunction against the companies and owners, restitution and civil penalties.
Peterson said he believes Regenerative Medicine has vacated its former clinic location in Omaha. He did not know whether the companies and owners continue to operate in any other locations in Nebraska.
In addition to their clinic in Omaha, the Autors have been affiliated with clinics in Arizona, Florida, Idaho, Montana, Vermont, Virginia and Washington, according to Peterson’s office.
A person who answered Stem Cell Centers’ national phone number agreed to relay a message seeking comment to the Autors. They did not respond immediately Thursday.
In a story last year in the Spokane, Washington, Spokesman-Review newspaper, Autor claimed to have treated between 8,000 and 10,000 patients at the seven clinics he and his wife own.
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