UC Irvine study exposes risks of direct-to-consumer stem cell, exosome COVID-19 therapy ads

Irvine, Calif., Oct. 26, 2023 — A study from the University of California, Irvine has revealed that in 2022, 38 North American businesses used direct-to-consumer advertising to promote unproven stem cell interventions and exosome products as purported treatments and preventatives for COVID-19. Collectively, these organizations operated or facilitated access to 60 clinics – with 24 in the U.S. and 22 in Mexico – accounting for 75 percent of the global marketplace, which also includes clinics in Guatemala, Malaysia, Poland and Spain.

Findings recently published online in the journal Stem Cell Reports show a disturbing trend of businesses capitalizing on the public health crisis. The most common marketing pitch, used by 36 of the 38, was for allegedly treating long COVID, while six offered “immune boosters,” five claimed to have therapies for those in the acute infection phase, and two provided so-called preventative remedies.

Health hazards posed by such untested interventions can range from minor complications to very serious adverse events such as pulmonary embolisms, cardiovascular problems and acute bacterial infections. In addition, consumers are also at financial risk, with costs ranging from $2,950 to $25,000, which are out-of-pocket expenses, as these treatments are not covered by insurance.

“Enterprises operating in this marketplace are overwhelmingly targeting individuals suffering from long COVID,” said Leigh Turner, professor of health, society and behavior in UCI’s Program in Public Health and the study’s corresponding author. “That’s understandable, since members of that population continue to experience significant health issues, but it’s also very alarming, because these people are not accessing evidence-based treatments that have been reviewed and approved by national regulators. When going online looking for stem cell or exosome treatments, people need to be alert to the possibility of scams.”

The fact that 24 of the identified clinics are based in the U.S. is striking, as U.S. agencies such as the Federal Trade Commission and the Food and Drug Administration have issued warning letters to companies making misleading claims about unproven stem cell and exosome products.

This paradox, according to Turner, is because these businesses operate in what he describes as a “fluid, shape-shifting marketplace” in which only some stop marketing the interventions after receiving such warnings, while others avoid detection by regulatory and law enforcement agencies, and new clinics open.

The UCI researchers employed three complementary methods, beginning in 2021, to investigate companies engaged in direct-to-consumer marketing of purported stem cell and exome products for treating COVID-19.

These techniques included gathering information from an online database of such businesses in the U.S.; performing internet searches to identify international companies and previously undetected U.S. ones; and reviewing the websites of businesses identified in a previous article that addressed ethical, regulatory and scientific concerns related to the selling of unproven stem cell interventions. After the initial data mining and content analysis, all websites were revisited, reanalyzed and fact-checked for a final time in October 2022 to ensure that the most recent marketing representations were captured.

“Our findings should be of value to patients and their loved ones, policymakers, stem cell researchers, clinicians, and regulatory and law enforcement agencies as they clearly highlight the need for further regulatory oversight, research, testing and approval of stem cell treatments and exosome therapies for COVID-19,” Turner said. “In addition to the possibility of harm to individuals, there is also what we might think of as ‘collective harms,’ such as patients paying for purported treatments marketed on a direct-to-consumer basis instead of participating in well-designed and carefully controlled clinical trials that could generate meaningful scientific knowledge that can be applied to the public good.”

The UCI study team also included Juan Ramon Martinez Jr., Shemms Najjar, Thevin Rajapaksha Arachchilage and Jia Chieng Wang. All four were members of Turner’s Health Ethics Research Group and recently graduated from the UCI Program in Public Health’s M.P.H. program.

Support for this project was provided by The Pew Charitable Trusts.

About the University of California, Irvine: Founded in 1965, UCI is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. For more on UCI, visit www.uci.edu.

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