FDA Takes Action Against ‘Bogus Stem Cell Clinics’
Officials at the Food and Drug Administration (FDA) are preparing to crack down on stem cell clinics in the United States that advertise pricey treatments for a variety of treatments, but don’t provide any scientific evidence that they work.
As many as 200 stem cell clinics claim to offer therapies that help conditions ranging from autism to multiple sclerosis (MS), to erectile dysfunction (ED), but there are no studies to show that the treatments are legitimate. Typically, these “clinics” have avoided heavy regulation, partly because they use a patient’s own cells, and because they don’t do much to those cells before they inject them.
But that’s about to change. In recently-issued guidelines, the FDA explains that the stem cells used in these clinics are considered drugs and cannot be used on patients before first undergoing a rigorous approval process. The agency has scheduled a hearing for April. [1]
In December, the agency issued a warning letter to several cell clinics informing owners that the treatments they offer did not meet FDA standards, and that they needed a valid biologics license in order to keep the clinics operating.
In order to obtain a license, regulators said, they must be able to prove the safety and efficacy for the product’s intended use. These products can be used on humans in the developmental stage, but “only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations,” the agency instructed. [2]
Stem cell clinics have fallen under harsh scrutiny after it was revealed that some stem cell researchers had made “critical errors” and “falsified data,” in one case leading to the retraction of studies from a prestigious medical journal, as well as the studies’ author being stripped of her doctorate degree.
Two patients in Florida died a few years ago after receiving stem cell injections; a California woman suffered painful bone fragments in her eyelids when she underwent a stem cell facelift; and yet another patient developed nasal tissue in her spine that secreted mucous after undergoing stem cell treatment in an attempt to cure her paralysis.
“It’s a huge, unapproved human experiment,” said Paul Knoepfler, a stem cell researcher at the University of California at Davis who tracks for-profit stem cell clinics on his blog.
Other experts agree.
“If it’s not safe and it’s not going to help patients,” said Leigh Turner, a bioethicist at the University of Minnesota who has spent years pressuring the FDA to take action against the clinics, “it’s just predatory behavior.”
But some patients are willing to drop nearly $9,000 for one of the aforementioned stem cell facelifts. The process involves injecting stem cells or stem cell extracts into the skin along with fat. The procedure offers no benefit over standard facelifts, according to an American Society of Plastic Surgeons task force.
It’s not just clinics and surgical procedures the FDA has to worry about. Celebrities like Kim Kardashian use products like $500 stem cell facials even though some experts say that applying stem cells topically won’t regenerate human skin.
But for some, the idea of being able to erase years of aging and wrinkles is worth the hundreds of dollars that many of these bogus products cost. I would try some Aloe vera, first.
Stem cells actually hold a good bit of promise, but procedures to treat serious diseases are still years away, and will likely always be controversial.
And as for reversing aging…well, you might be able to reap more benefits from inexpensive products found in your own kitchen.
Sources:
[1] STAT News
[2] Drug Discovery & Development
Featured image sourced and modified from: IRIS SCHNEIDER / STAT NEWS
