More than 300 companies are marketing unapproved stem cell procedures at more than 500 clinics in the U.S., according to a new study based on internet searches.
Found in embryos, umbilical cord blood and adult bone marrow, stem cells have the potential to develop into any type of specialized cell in the body.
Stem cells can be used to help repair areas damaged by disease or injury, according to the U.S. Department of Health and Human Services.
In the U.S., stem cell therapies generally require Food and Drug Administration approval before they can be marketed, and the FDA has only approved one product so far, for blood disorders.
But many clinics in the U.S. now advertise a variety of stem cell treatments that have not been approved, ranging from cosmetic procedures like facelifts and breast enlargement, to therapies for neurological diseases or sports injuries, according to the new study.
“Many of these marketing claims raise significant ethical issues given the lack of peer-reviewed evidence that advertised stem cell interventions are safe and efficacious for the treatment of particular diseases,” the researchers write in the journal Cell Stem Cell.
Searching the internet, the researchers found 351 companies marketing unapproved stem cell procedures at 570 clinics in the U.S., most commonly in California, Florida, Texas, Colorado, Arizona and New York.
These procedures are not heavily regulated because they use cells from a patient’s own body. But earlier this year, the FDA issued draft guidelines asserting that the stem cells used in most procedures are drugs and should require a rigorous approval process before they can be used. The draft guidelines will be discussed further at a public hearing in mid-September (bit.ly/1RoFZe1).
Unapproved stem cell therapies have no conclusive evidence of safety or effectiveness, Turner said.
“If you’re thinking about having an unapproved stem cell treatment, there are things you can look for,” he said. “If a place offers one treatment for 30 to 40 diseases, it’s extremely unlikely that it’s going to be effective.”
It’s not surprising that people with terminal or degenerative diseases would seek solutions on the internet, or that businesses would be able to take advantage of these vulnerable individuals, charging them $30,000 for a treatment that doesn’t improve their health, he said.
“We’re all a lot more vulnerable to businesses making inaccurate marketing claims than we might think,” Turner said.
He said he doesn’t mean to suggest that all uses of stem cells are dangerous or unethical, as approved stem cell treatments for conditions like leukemia can be life-saving.
“It is the wild west, there are lots of clinics making all kinds of promises they can’t necessarily deliver on,” said Mary Ann Chirba, professor of legal reasoning, research and writing at Boston College Law School, who was not part of the new study. “But that’s not to say that all clinicians who are working in this area are charlatans.”
There’s a “clumsy architecture” for regulating emerging therapies, Chirba told Reuters Health by email.
“Any responsible person, myself included, wants regulation,” but the rules currently in place are not effective, and the draft FDA guidelines may actually be too restrictive, and make it too difficult for patients to get access to these types of treatment at all, she said.
In the meantime, the FDA cautions on its web site, “If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.”
SOURCE: bit.ly/29qbjj3 Cell Stem Cell, online June 30, 2016.