22/02/2024

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Unapproved stem-cell therapies marketed to people with long COVID

Unapproved stem-cell therapies marketed to people with long COVID

New research has identified 38 direct-to-consumer businesses marketing stem-cell treatments and exosome therapies for COVID-19 infections and, especially, long COVID, despite lacking approval by US Food and Drug Administration and other regulatory body in the United States. Descriptions of the businesses and an analysis of their marketing strategies are published in Stem Cell Reports.

The 38 businesses operated or facilitated access to 60 clinics, almost all in the United States and Mexico, the authors said. The businesses were identified via web-based searches including “stem cell COVID treatments,” “stem cell clinic treating COVID-19,” and “exosome therapy for COVID-19.”

Treatment costs as high as $25,000

Once businesses were identified, the researchers, from the University of California, Irvine, tracked how many clinics the companies operated, and they searched social media sites and platforms for the businesses.

Twenty-four of the 60 clinics (40%) listed on websites of the identified businesses were in the United States, 22 (37%) were in Mexico, four (7%) were in Ukraine, and two (3%) were in the Cayman Islands. Guatemala, Malaysia, Panama, Philippines, Poland, Spain, Thailand, and the United Arab Emirates had one clinic each (around 2% per country).

Thirty-six of the 38 marketed their stem cell and exosome products as treatments for long COVID, six advertised them as “immune boosters,” five claimed to treat patients in the acute infection phase, and two claimed their products were preventive.

Twenty businesses (53%) sold umbilical cord blood or umbilical cord tissue–derived mesenchymal stem cells, and 16 (42%) marketed exosomes. Methods for treatment delivery varied, with 58% reportedly using intravenous infusions, and 21% claimed they nebulized their product. Eleven businesses (29%) did not specify how they administered their products, the authors said.

Only nine of the businesses clearly advertised how much services cost, with the lowest treatment available at $2,950. The most expensive was $25,000, and the average listed cost for patients was $11,322.

Targeting long-COVID patients

Almost all online and social media advertising was aimed toward relieving symptoms of long COVID, including brain fog and fatigue.

The patients being targeted by such marketing claims are particularly vulnerable.

“The patients being targeted by such marketing claims are particularly vulnerable, ” said Leigh Turner, PhD, lead author and a bioethics professor in the University of California, Irvine Department of Health, Society, and Behavior in a press release from Cell Press, the journal’s publisher.

“They’re suffering, and in some cases, they’ve been suffering for a long time, making them highly susceptible to misleading marketing representations and persuasive marketing pitches.”

In a conclusion on the study, the authors wrote that, until evidence of efficacy is studied and approved by regulatory bodies, vulnerable patients will be exploited by online businesses.

“Further clinical research should provide insight into whether specific stem cell-based interventions or exosome products are backed by sufficient evidence of safety and efficacy related to treating or preventing COVID-19 to warrant premarketing approval or emergency use authorization by national regulators,” the authors wrote. “Absent such evidence, patients are vulnerable to being exploited by businesses using direct-to-consumer online advertising to make persuasive but unjustified claims about treating or preventing COVID-19.”