More than 350 U.S. companies are offering unapproved stem cell procedures, said researchers from the University of California, Davis, on Thursday. Centers may be conducting treatments for neurological disorders, cardiac disease, orthopedic injuries and others in a somewhat unlawful way.
Paul Knoepfler, professor of cell biology and human anatomy at UC Davis, said that Americans in most states could obtain “stem cell treatments” locally. He said people previously had to travel to Mexico or the Caribbean Islands, to do the same. Researchers discovered places offering these treatments after looking for keywords on the Internet.
Florida continues on the list with 104 clinics, Texas with 71, Colorado with 37 and Arizona with 36. The team said in a statement that 61 percent of analyzed businesses offer “fat-delivered stem cell interventions,” while 48 percent offer “bone-marrow-based procedures.”
More than 300 clinics are currently advertising orthopedic treatments, while more than 150 businesses are using stem cell treatments. Others are treating sports injuries, immune disorders, and neurological diseases, said UC Davis.
Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics, said a new market segment of stem cells has been increasing over the last years. He said researchers didn’t know about the impact of the market and that it should be regulated.
“Where are the brakes? Where are the regulatory bodies? And how did this entire industry come into being in a country where stem cell-based interventions and the medical devices that produce them are supposed to be regulated by the FDA?” said Turner in a statement.
— Hank Greely (@HankGreelyLSJU) July 1, 2016
Is the Food and Drug Administration aware of the scope of stem cell clinics?
Both professors suggested that cosmetic surgeons and neuropathy in the U.S. are currently offering unapproved stem cell interventions. They said that ‘pioneers’ in the field are training people to conduct new stem cell procedures.
Researchers wondered if federal institutions like the Food and Drug Administration (FDA) are aware of the scope of clinics offering unapproved stem cell treatments. They said businesses are providing treatment for more than 40 different diseases.
More than 200 clinics in the US offer unapproved stem cell therapies. The FDA is preparing to crack down on them https://t.co/wSX89KJloC
— STAT (@statnews) February 8, 2016
According to Professor Turner, “people should receive access to “safe and efficacious interventions. Clinics should not be allowed to conduct unapproved experiments with humans such as cell-based interventions,” he added.
Professor Knoepfler said he is worried about the public perception of stem cell treatments. He argued that interventions should be carefully regulated by institutions like the FDA, to create a positive perception of their impact.
The FDA has authorized just a few stem cell treatments in the United States, said The Washington Post. Patients attending to clinics mentioned in the study would be paying thousands of dollars for unapproved practices.
Michael Werner, executive director of the Alliance for Regenerative Medicine, told WP that stem cell treatments should be strictly regulated, like all technologies and new medicines approved in the nation.
Here is a TED-Ed video featuring Educator Craig A. Kohn, talking about the impact of stem cells: