Sales of Unproven, Unapproved Stem Cell Therapies Are Booming

By Robert Preidt
HealthDay Reporter

MONDAY, Nov. 8, 2021 (HealthDay News) — The sale of unproven and unapproved stem cell therapies has skyrocketed within the United States, based on a brand new five-year examine.

The examine discovered a fourfold bounce since 2016 within the availability of the therapies, which declare to do every part from relieving ache to slowing getting older.

People who use these therapies are needlessly spending 1000’s of {dollars} and might be placing their well being in danger, examine creator Leigh Turner warned.

“One of essentially the most troubling options of this market is that companies promoting unproven and non-FDA-approved stem cell merchandise usually use advertising misrepresentations and aggressive gross sales ways to take advantage of the hope, struggling, concern or desperation of sufferers,” mentioned Turner, a professor of well being, society and conduct on the University of California (UC), Irvine.

Using on-line search instruments, the examine recognized 1,480 U.S. companies and a pair of,754 clinics providing purported stem cell therapies. That compares to 351 companies and 570 clinics that did so 5 years in the past.

The United States now has extra places providing such therapies than every other nation, together with people who had been as soon as scorching spots for so-called “stem cell tourism,” the findings confirmed.

Stem cell remedy, often known as regenerative drugs, has resulted in life-saving therapy of sufferers with sure kinds of most cancers and blood illnesses. But the security and effectiveness of stem cell merchandise wants additional testing, based on a college information launch.

In this examine, the states with the best variety of stem cell clinics are California (347), Texas (333) and Florida (310).

The findings had been printed on-line Nov. 4 within the journal Cell Stem Cell.

“Many of those ‘clinics’ are selling unlicensed and unproven stem cell merchandise and declare their interventions don’t require FDA approval,” mentioned Turner, a member of UC-Irvine’s stem cell analysis middle and ethics chief at its Institute for Clinical and Translational Science. “However, that could not be farther from the reality.”

Turner mentioned there may be widespread promotion of merchandise that do require authorization by the U.S. Food and Drug Administration earlier than advertising.

“In many instances, these clinics are utilizing deceptive promoting and predatory advertising methods,” he warned.

Claims concerning the therapies embody serving to with ache (85%+), orthopedic illnesses and accidents (46%+), and sports-related accidents (22%+). The claims vary from serving to with hair loss and slowing the getting older course of to strengthening the immune system to guard in opposition to SARS-CoV-2, the virus that causes COVID-19.

Out-of-pocket prices for the therapies vary from $1,200 to $28,000, with a mean of about $5,100.

Unproven and unapproved stem cell merchandise pose quite a few dangers to sufferers and have triggered some severe hurt to some, based on Turner, who added that the state of affairs is more likely to proceed except the FDA and different companies step up enforcement.

More info

Read a U.S. Food and Drug Administration warning about unapproved stem cell therapies.

SOURCE: University of California, Irvine, information launch, Nov. 4, 2021