Stem cell treatments are still in the experimental stage, with a lot more advanced research required before treatments make it into the mainstream. However, that hasn’t stopped American “stem-cell tourists” from traveling to unregulated clinics in Mexico, the Caribbean, and China searching for stem-cell treatments for just about anything, from heart treatments to facelifts.
Now, in a study published in the journal Cell Stem Cell, researchers have found a total of 351 U.S. businesses offering unapproved stem cell treatments. There are at least 570 American-based clinics offering experimental stem cell-based medical procedures within the United States.
Most of the treatments were marketed directly to customers, praying on those who are desperately seeking help for a terminal illness. This kind of marketing is against federal regulations; however, it appears to be happening on a regular basis. In the paper, the authors wrote:
“There are related ethical concerns about information provided to prospective clients and the veracity of marketing claims, the safety and efficacy of advertised procedures, and the risk of physical, emotional, and financial harm to already ill or injured and vulnerable individuals.”
Paul Knoepfler, a professor of cell biology and human anatomy at UC Davis, an associate investigator at the Institute for Pediatric Regenerative Medicine at Shriners Hospital for Children Northern California, and author of the study, said in a statement:
“In almost every state now, people can go locally to get stem cell ‘treatments.’ 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.
“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.”
Researcher and co-author Leigh Turner, from the University of Minnesota’s Center for Bioethics, said how he was surprised that these clinics have been operating, since they are unproven and unapproved by federal regulators.
He added that most concerning is that this may be causing serious harm to patients. In the U.S., people have a misconception that everything is regulated; however, there are a lot of clinics that are unregulated.
Many of the websites intentionally blur the differences between approved, evidence-based scientific practices and quack procedures. Because so much has been written about stem cell research, it would not be hard to convince the general public that these treatments work.
The websites of these clinics sometimes link to published medical studies showing therapies to look legitimate. Turner said in the statement:
“When you go on the Internet, what comes up, the first thing you see are these businesses. The websites are well-done, with links to scientific studies and patient testimonials.”
Researchers have been studying stem cells for some time now, looking at their ability to repair damaged tissues. However, they have only achieved limited success. The U.S. Food and Drug Administration (FDA) has only approved a few stem-cell treatments, with treatments for most conditions still largely unproven. On the FDA website it states:
“In theory, stem cells may advance the treatment of many other diseases or conditions; however, at this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits.”
The researchers also found that not only were cosmetic surgeons and naturopaths offering the unapproved stem cell interventions, but the “pioneers” were also training others to do the same. It is not clearly understood whether the FDA and state medical boards have been asleep at the wheel, or why they seem to be taking only minimal actions. Turner said:
“From around 2009 to the present, businesses have been entering the marketplace on a routine basis. They’ve been coming in making marketing assertions about stem cells treating 30-40 different diseases, and no one’s taking meaningful regulatory action.
“Does that mean that people are getting access to safe and efficacious interventions or is there basically unapproved human experimentation taking place where people are going to these businesses and receiving experimental investigational cell-based interventions without being given a meaningful account of the lack of knowledge and evidence that they’re being charged for?”
One in five clinics was found to be marketing treatments with stem cells that were derived from other people. Two clinics even offer “bovine amniotic cells” to patients (cells derived from the amniotic fluid of cows). There is also no way of finding out if these clinics are even providing stem cells, let alone whether they are effective.
Often, the clinics claim it is a clinical trial; however, in reality, it is a for-profit center that is conducting experimental procedures. If it was a clinical trial, then the patient would most often get paid, not the clinics.
Stem cells are primitive cells that can be guided into becoming nearly any type of cell, such as a nerve cell, skin cell, or red blood cell. This in turn could help to repair parts of the body that have suffered from injury or disease.
It is also important to point out that even if real stem cells are being used, there are still dangers involved. Stem cells have been known to increase in size and cause tumors.
The researchers cited a case where a stroke patient had traveled to China, Argentina, and Mexico. He had spent hundreds of thousands of dollars on different stem cell treatments, resulting in only a painful growth on his spine.
In the paper, the authors make it clear what major problems exist:
“This commercial activity generates a host of serious ethical, scientific, legal, regulatory, and policy concerns. Perhaps the most obvious regulatory question is whether businesses advertising nonhomologous autologous, allogeneic, ‘induced pluripotent,’ or xenogeneic ‘stem cell therapies’ are exposing their clients to noncompliant cell-based interventions.
“Such practices also prompt ethical concerns about the safety and efficacy of marketed interventions, accuracy in advertising, the quality of informed consent, and the exposure of vulnerable individuals to unjustifiable risks.”
What most patients do not understand is, by having unapproved and unproven stem cell interventions, it decreases their chances of qualifying for FDA-cleared and institutional review board-approved clinical trials that comply with federal regulations. The FDA wrote that it was:
“Concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.”
The study authors have not accused the clinics of illegal operations; they have simply called for federal officials to step in and address the oversight. The researchers believe that additional discussions into the ethical, legal, and medical ramifications of these clinics need to be conducted.
There is no doubt that stem cells and stem cell research may provide greater understanding in diseases and new therapies. However, what these clinics are offering is a completely different case.