Oct. 26, 2023 – Companies marketing expensive and unproven stem cell therapies are targeting patients with long COVID – an often debilitating condition that to date has no proven treatments, according to a report published today.
Researchers identified 38 direct-to-consumer businesses selling purported stem cell therapies to prevent and treat the virus – 36 of which also claim to treat post-COVID syndrome.
“There’s an important opportunity here for regulators to understand there are still quite a number of businesses making problematic advertising claims,” said Leigh Turner, PhD, the first author of a study on the issue and a bioethics professor at the University of California, Irvine Department of Health, Society, and Behavior. “I don’t think this is going to go away anytime soon. It needs to be a high priority.”
Stem cells, sometimes called the body’s “master cells,” can generate new cell types – something no other cell in the body can do. And while they have the potential to repair and regenerate cells, these therapies have not been approved by regulatory bodies and are not backed by convincing safety and efficacy data.
The FDA issued a warning in 2019 against stem cell therapies to treat COVID-19.
Of the 60 clinics operated by these businesses, 24 are based in the U.S. and 22 are in Mexico, with other clinics in the Cayman Islands, Guatemala, Malaysia, Panama, the Philippines, Poland, Spain, Thailand, Ukraine, and the United Arab Emirates.
“It was interesting to me the extent to which these were businesses operating in the U.S., not in far-flung places,” Turner said.
According to the report, clinics charge anywhere from $2,950 to $25,000 for stem cell products.
Many people with long COVID deal with symptoms such as brain fog, extreme fatigue, and severe headaches that linger for months or even years. One in 10 people with the virus will get post-COVID syndrome. The severity of the symptoms, and the lack of treatments, make patients particularly vulnerable to false claims, said Kristin Englund, MD, an infectious disease specialist who runs the Cleveland Clinic’s reCOVer clinic for long COVID patients.
Englund said several patients have asked about stem cell therapies, and she warns them that there could be potential side effects without much, if any, benefit. Companies often try to claim a medical benefit without scientific evidence and without being recognized by a regulatory agency, she said.
“When you work with this population, you see how desperate they can get to return to the lives they lived pre-COVID,” she said. “Some of the patients we’re seeing, they’ve been going on 3 years with these symptoms. At this time, there is no single diagnosis, no single treatment, and that is tremendously frustrating for patients.”
Julia Moore Vogel, PhD, a computational biologist and researcher at Scripps Research, has seen this problem through both a patient and scientist lens. Before catching the virus in July 2020, the 38-year-old was a long-distance runner. Now, after dealing with long COVID for 3 years, she counts her steps so she doesn’t get too tired.
And while she has tried potential low-risk therapies like supplements – which didn’t work for her – she would not use stem cell therapies, given the lack of solid research.
“I of course remember, in school, stem cell therapies being something that was very much an area of interest,” she said. “I would just really need to see the data before I could feel confident about trying it.”
Though the National Institutes of Health has launched multiple clinical trials focused on treating long COVID, and the FDA has authorized several stem cell clinical trials for long COVID, there is still much to learn about post-viral syndromes in general, said Michael R. Jordan, MD, an infectious disease doctor at Tufts University in Medford, MA.
“There are a number of observational cohort studies and clinical trials in progress to assess various treatments for long COVID,” he said. “But what is important is there is no proven treatment at this point, and recommendations are for patients to work with licensed qualified and experienced health care providers for symptom management.”
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2023-10-26 20:33:04
