Attorney General Doug Peterson filed a Complaint today in the District Court of Douglas County against Omaha Stem Cells, LLC, Regenerative Medicine and Anti-Aging Institutes of Omaha, LLC, Stem Cell Centers, LLC and Travis and Emily Autor (collectively “the Defendants”). The case relates to the Defendants’ marketing and sale of stem cell therapy to consumers, often following aggressive marketing through local media and in-person seminars throughout Nebraska and Iowa. The Defendants operated a clinic until recently in Omaha. The Attorney General conducted his investigation in cooperation with Iowa Attorney General Tom Miller, who filed a similar lawsuit today in Iowa.
The Attorney General alleges the Defendants made over $2 million by making deceptive and misleading statements to consumers regarding the ability of their stem cell therapy to treat specific diseases and health conditions, including joint pain, back pain, osteoarthritis, neuropathy, and COPD. The lawsuit also alleges the Defendants misrepresented that stem cell therapy is safe and that larger doses are more effective, without possessing the necessary evidence to make these types of claims.
In his lawsuit, the Attorney General acknowledges prior statements by the FDA that stem cells “have the potential to repair, restore, replace and regenerate cells,” and in the future “could possibly be used to treat many medical conditions and diseases.” However, stem cell use for most medical conditions remains unproven and, therefore, unapproved by the FDA. In September 2019, the FDA warned consumers that the unapproved use of stem cell treatments can be “particularly unsafe,” and may lead to adverse reactions, such as the failure of cells to function as expected and tumor growth.
Unfortunately, this warning may have come too late for some consumers in Nebraska. In December 2019, the FDA issued a more specific Public Safety Notification regarding multiple reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. According to the Attorney General’s lawsuit, the Defendants were advertising and administering unapproved exosome products to consumers.
Attorney General Peterson stated, “Consumers are entitled to accurate and truthful information about any product or service, but especially those products that affect their health and wellbeing. With today’s filing, we remind all healthcare providers and other businesses that they will be held accountable for the representations they make to consumers.”
Consumers in Nebraska, and across the country, need to heed these warnings when it comes to stem cell products. According to the Attorney General, Travis and Emily Autor operate a network of companies across the country that advertise and sell stem cell therapy directly to consumers. In addition to their clinic in Omaha, the Autors have been affiliated with clinics located in Arizona, Florida, Idaho, Montana, Vermont, Virginia, and Washington.
According to the FDA, those considering whether to undergo treatment with stem cell products, including exosomes, should:
Ask if the FDA has reviewed the treatment before getting treatment—even if the stem cells are their own. Ask their health care provider to confirm this information.
Make sure they understand the entire process and known risks before consenting to participate in a clinical trial. To participate in a clinical trial that requires an Investigational New Drug Application (IND), the consumer must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects.
Be cautious when considering treatment in another country. Know that the FDA does not have oversight of treatments done in other countries.