乌鸦传媒

In the age of social distancing, one stem cell clinic has decided to make its products -- which it strongly suggests can prevent COVID-19 -- available for home delivery.

No injections are required: instead, a nebulizer allows patients to inhale exosomes directly into their lungs, according to a YouTube video posted by the Los Angeles-based that has since been (though a text-only version ).

"This procedure was invented during the coronavirus outbreak so patients could get the full benefit of exosome vapor to repair their lungs, strengthen their immune systems, and interrupt 'virus multiplication' WITHOUT risking a trip to their local clinic or hospital (where they could end up catching COVID-19)," the text below the video reads.

Leigh Turner, PhD, a University of Minnesota bioethicist who has been closely following the direct-to-consumer stem cell industry, said the Novus Center's approach is certainly a novel one.

"It's not often that you see these clinics taking a do-it-yourself angle," Turner told 乌鸦传媒. "They're sending these kits to people's houses, having them put masks on their face and inhaling whatever is in those products. I'm not optimistic people will benefit."

Stem cell companies have been using the coronavirus pandemic to push their dubious products in many ways, according to a new paper by Turner about to be published in Cell: Stem Cell (it's currently ).

Clinics in , , , , and Florida are all selling stem cell or exosome treatments that they claim can boost immunity, enhance lung health, and inhibit viral replication -- making strong suggestions about a place in COVID-19 prevention. The Arizona clinic even cites a South China Morning Post article about a 65-year-old woman in China who had COVID-19 but was healed thanks to stem cells.

In , the Novus Center also references a Chinese study -- albeit one that's not yet recruiting participants, -- in order to give credence to the efficacy of its products, even though there has been limited study of any type of stem cells for the treatment of COVID-19 anywhere in the world.

"Do they have any notion of a dose?" Turner asked. "How many cells are they putting into people? Has it been tested for safety?"

Novus said in a video that it gets its product from Kimera Labs, one of the largest distributors in the direct-to-consumer stem cell market.

"This gets into Liveyon territory," Turner said, referencing a stem cell distribution company that was reprimanded by the FDA for failing to maintain good patient safety practices after a spate of infections was tied to their injections. "Are they [Novus] checking to make sure they're not releasing contaminated product?"

"When you're inhaling a product, a lot can go wrong," Turner added. "There's no evidence this will prevent COVID-19 and it may even hurt somebody."

Other players in the direct-to-consumer stem cell industry have seized on coronavirus-related opportunities for promoting their products.

Biobanks have urged healthy clients to store their own stem cells for future use if they develop COVID-19, Turner reported, though the YouTube and Facebook posts he cited have since been removed.

Two organizations that promote stem cells -- the American Academy of Stem Cell Physicians and the American Society for Interventional Pain Physicians -- have issued public messaging about stem cells, which Turner says "risks spreading the misrepresentation that a substantial body of evidence already supports the safe and efficacious use of stem cell products in the care of individuals with COVID-19."

Turner also highlighted concerns that many clinical trials approved to test stem cells in COVID-19 patients lack blinding, randomization, and controls; have a small sample size; are single-center; and are "unlikely to generate high-quality safety and efficacy data."

"An additional concern with such poorly designed or very preliminary studies is that despite not having the capacity to generate robust evidence, they could lead to patients with COVID-19 seeking access to unproven stem cell products on a right-to-try basis," he wrote.

Regulators have started to warn stem cell companies playing to coronavirus fears; starting in April, the FDA has sent warning letters to , the , , and . The Federal Trade Commission issued warning letters to , , the , , and .

The FDA has long been trying to get a handle on unapproved stem cell therapies. In 2017, the agency issued guidance on regenerative medicine products, with a November 2020 deadline for full compliance. It has since sent numerous warning letters to companies, though many continue to push therapies ahead of the fall deadline.

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