Stem cell sales skyrocket despite lacking FDA approval, study finds

Biologics

The number of businesses and medical clinics advertising stem cell-based therapies has skyrocketed in the U.S. over the past five years, according to a study published in Cell Stem Cell Nov. 4. 

In 2016, there were 351 U.S. businesses and 570 clinics selling unlicensed and unproven stem cell products, the study found. As of March 2021, the numbers multiplied by more than four times to 1,480 businesses operating 2,754 clinics.

The largest concentrations of such clinics were found to be in California (347), Florida (333) and Texas (310). According to the study, these three states comprise 35.9 percent of all U.S. clinics.

"One of the most troubling features of this marketplace is that businesses selling unproven and non-FDA-approved stem cell products often use marketing misrepresentations and aggressive sales tactics to exploit the hope, suffering, fear or desperation of patients," said Leigh Turner, PhD, author of the analysis and a professor of health, society and behavior at the University of California Irvine.

Stem cell-based therapies, unlicensed and unapproved by the FDA, began being sold in the U.S. nearly two decades ago and claim to renew and repair damaged tissues in various orthopedic, cardiovascular and autoimmune conditions, among others.

Of 1,480 businesses, 1,262 claim to use stem cells to treat painful symptoms, 689 claim to treat orthopedic diseases and injuries and 339 purportedly treat sports-related injuries, the study found. Other products' claims range from targeting hair loss and aging to boosting the immune system as a way to protect against COVID-19.

"Many of these 'clinics' are promoting unlicensed and unproven stem cell products and claim their interventions do not require FDA approval," Dr. Turner said. "However, that couldn't be further from the truth. I found that there is widespread promotion of products that do, in fact, require premarketing authorization by the FDA. In many cases, these clinics are using misleading advertising and predatory marketing techniques."

Patients are spending thousands on stem cell-based products — out-of-pocket costs range from $1,200 to $28,000, with an average price of about $5,100. Such unlicensed and unapproved products pose various risks to patients, and adverse events resulting from their administration are likely underreported to the FDA, according to the study.

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