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Sales of Unproven, Unapproved Stem Cell Therapies Are Booming

By Robert Preidt
Health Day reporter

MONDAY, November 8, 2021 (HealthDay News) – The sale of unproven and unapproved stem cell treatments has exploded in the United States, according to a new five-year study.

The study found a quadrupling since 2016 in the availability of treatments, which claim to do everything from relieving pain to slowing aging.

People who use these treatments are spending thousands of dollars needlessly and could put their health at risk, warned study author Leigh Turner.

“One of the most troubling characteristics of this market is that companies that sell unproven, non-FDA approved stem cell products often use false marketing claims and aggressive sales tactics to exploit the hope, the suffering, fear or despair of patients, ”said Turner, a professor of health, society and behavior at the University of California (UC), Irvine.

Using online research tools, the study identified 1,480 US companies and 2,754 clinics offering so-called stem cell treatments. This compares to 351 companies and 570 clinics that did so five years ago.

The United States now has more places offering such treatments than any other country, including those that were once hot spots for so-called “stem cell tourism,” the results showed.

Stem cell therapy, also known as regenerative medicine, has been used to treat patients with certain types of cancer and blood diseases. But the safety and efficacy of stem cell products require additional testing, according to an academic press release.

In this study, the states with the most stem cell clinics were California (347), Texas (333), and Florida (310).

The results were published online Nov. 4 in the journal Stem cell.

“Many of these ‘clinics’ promote unauthorized and unproven stem cell products and claim that their procedures do not require FDA approval,” said Turner, a member of the Stem Cell Research Center. UC-Irvine and Ethics Officer at its Institute of Clinical and Translational Sciences. . “However, that couldn’t be further from the truth.”

Turner said there is a wide promotion of products that require approval from the United States Food and Drug Administration before they can be marketed.

“In many cases, these clinics use deceptive advertising and predatory marketing techniques,” he warned.

Treatment claims include pain relief (85% +), orthopedic illnesses and injuries (46% +), and sports-related injuries (22% +). The claims range from helping with hair loss and slowing the aging process to strengthening the immune system to protect against SARS-CoV-2, the virus that causes COVID-19.

Reimbursable costs for treatments range from $ 1,200 to $ 28,000, with an average of around $ 5,100.

The unproven and unapproved stem cell products pose many risks to patients and have caused serious harm to some, according to Turner, who added that the situation should continue unless the FDA and other agencies do not. ‘intensify their application.

More information

Read a warning from the United States Food and Drug Administration regarding unapproved stem cell therapy.

SOURCE: University of California, Irvine, press release, November 4, 2021

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