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There’s a Huge Unregulated Stem Cell Industry in the US

A new study finds well over 550 clinics in the US are selling unapproved stem cell treatments.
July 2, 2016, 8:00pm
A map of all the clinics offering unapproved stem cell therapies. Image: Knoepfler, et al.

As the blank slates of cellular biology, stem cells have helped scientists do some pretty amazing things like grow an infant human heart or a new foreskin. Still, they remain a controversial and ethically complicated area of research, and many researchers think stem cells are "dangerously overhyped" as a medical treatment. This is because media outlets love to bill stem cells as a miracle cure for everything from baldness to blindness, conclusions that are often based on tenuous experimental evidence.


But despite the shoddy science, people have clearly taken notice of the "miracle" of stem cells. This has led to a thriving stem cell tourism industry, where people pay big bucks to fly to places with more relaxed medical regulations like China and Latin America to receive unproven stem cell treatments for serious illnesses. Yet according to a new study published this week in Cell, there's no need to travel outside of the US for your bogus stem cell therapy—in fact, there's probably a doctor selling unapproved stem cell treatments right down the road.

"In almost every state now, people can go locally to get stem cell 'treatments," said Paul Knoepfler, a stem cell researcher at UC Davis and one of the authors of the study. "Many people in larger metropolitan areas can just drive 15 minutes to find a clinic offering these kinds of services instead of, say, traveling to Mexico or the Caribbean."

While the proliferation of unproven stem cell miracle cures is troubling, there is no doubt that stem cells themselves are miraculous. As an undifferentiated cell, they are capable of becoming any one of a large number of specialized cells, whether it's blood, brain, or embryonic, and are also capable of dividing nearly without limit in a living human or animal, making them one of the body's best repair mechanisms. Although researchers have been working with stem cells for decades and have shown their vast medical potential, bone marrow transplants remain the only non-experimental form of stem cell treatments.


This hasn't stopped unscrupulous clinics from touting some questionable stem cell applications, such as vaginal rejuvenation or hair loss, however. Using text mining and content analysis from the websites of companies offering stem cell therapies, Knoepfler and his co-author Leigh Turner identified 351 companies operating in 570 clinics in the US that were selling unapproved stem cell treatments (they provide a full list of the clinics and their websites in the paper). They say their analysis points to a troubling lack of regulatory oversight in the US, which could have serious consequences for stem cell research and uninformed patients.

"No one's taking meaningful regulatory action," said Turner, an associate professor at the University of Minnesota's Center for Bioethics. "Does that mean that people are getting access to safe and efficacious interventions or is there basically unapproved human experimentation taking place? 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?"

According to Knoepfler and Turner's analysis, the vast majority of these clinics offering unapproved stem cell therapies are concentrated in California and Florida. Most of these businesses were selling treatments for orthopedic issues, although other prominent conditions that were advertised included neurological diseases and immune disorders.

The proliferation of unregulated stem cell companies has a number of troubling consequences. In the best case scenario, an unwitting customer sinks thousands of dollars into an unproven cosmetic procedure. In the worst case scenario, a patient with a serious illness banks their treatment on an experimental stem cell procedure without realizing the remoteness of its success. It also has serious implications for stem cell research as a field, which may be seen as illegitimate the more it is associated with these kinds of treatments.

"Over the years many people have begun to include these businesses in their overall impression of the stem cell field," said Knoepfler. "There is a real risk that…if we don't address [the proliferation of clinics] in a more proactive way, as we see negative outcomes for patients grow and people get mixed bags of information about stem cells, then this could really negatively impact the public perception of this research."