While focus has been on so-called "stem cell tourism" in the past, a new study shows that people don't have to chase down promises of anti-aging and structural repair therapies in China and the Caribbean. Most Americans living in metro areas are just a few minutes' drive away from one of the United States' 570 or so clinics offering stem cell treatments said to cure just about any ailment.
The researchers - a stem cell researcher and a bioethicist - scoured the Internet for businesses offering stem cell therapies in the United States. They mined the text and analyzed the content on the websites they found, packaging the findings in a Cell Stem Cell journal study titled "Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry."
In just about every state, people can find stem cell programs locally, said study author Paul Knoepfler, a UC Davis professor of biology and human anatomy. Knoepfler is also a researcher at Shriners Hospital's Institute for Pediatric Regenerative Medicine in Northern California.
"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," said Knoepfler. "I think this reflects a change from what we've seen documented in the past and is different from what we typically think about when we think of stem cell tourism."
The clinics selling direct-to-customer stem cell treatments were concentrated in six states. California had 113 clinics, Florida had 104, Texas had 71, Colorado had 37, Arizona had 36 and New York had 21.
Despite this proliferation of direct-to-customer clinics, the researchers found that few of the businesses offered pluripotent stem cells, the type that can replicate any other cell in the human body. Most of the stem cells came from fat and bone marrow, which were found in about 61 percent and 48 percent of clinics respectively.
The Promise Of Stem Cell Therapy
Though primitive, stem cells have the unique ability to create new cells. It's that potential to replace damaged and depleted cells that has led to all of the hype surrounding stem cells.
Much has been made about the ethics surrounding the use of embryonic stem cells, the type collected right after an egg has been fertilized.
And maybe regulation restricting research into embryonic stem cells, which are pluripotent, and the regular vetoes from then-President George W. Bush on embryonic research have given stem cell therapies the allure of a forbidden fruit or a fountain of youth red-taped off by bureaucrats.
Bush's vetoes didn't ban stem cell research, but prevented embryos from being destroyed in the name of science and narrowed the bounds of research into it. President Barack Obama in 2009 eased some of the restrictions on research into embryonic stem cells, allowing more federal funding to go into advancing the field.
Businesses may have taken advantage of the favorable press surrounding stem cell research then, because bioethicist Leigh Turner, of the University of Minnesota and the paper's co-author, notes that companies began routinely entering the market around that time. However, most of these treatments don't use the type of stem cells proven most effective.
These business have made claims about stem cell interventions treating dozens of diseases, yet there has been a lack of meaningful regulation, Turner stated.
Is this because people are accessing "safe and efficacious" treatment, Turner questioned. Or is this "unapproved human experimentation" that people participate in without being told in full about the lack of scientific evidence and knowledge on the cell-based interventions that they're being charged for?
This loosely regulated market offers hope to the hopeless, those given an end-of-life forecast by their doctors. But it all often results in a time sink and a money pit, plus there are myriad of dangers of unregulated, invasive treatments.
And for those looking for a cure to non-life-threatening ailments such as a bad back or cosmetic problems, these direct-to-customer clinics would make matters worse for them and tarnish the reputation of stem cell therapies. On top of that, it could disqualify some people from being accepted into fully regulated clinic trials, according to the researchers.
"Brakes ought to exist in a marketplace like this," said Turner. "But 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?"