A study has proven that there are at least 351 companies at 570 locations across the United States that are selling stem cell therapies that have not yet been fully verified by medical researchers, much less approved by the US Food and Drug Administration, states a report from the Los Angeles Times.
Paul Knoepfler, a stem cell researcher at the University of California, Davis, who has a doctorate in molecular pathology, and Leigh Turner, a bioethicist at the University of Minnesota whose area of study is on medical tourism, conducted the study. They did a thorough search of the internet to find companies marketing all kinds of stem cell treatments directly to patients and their families. The pair used close to a hundred search terms to identify as many websites as possible and turned up more results than they expected.
Turner said they expected a final count in the triple digits. He said,
Still, I did not expect to find 351 distinct businesses or 570 clinics.
Almost every state had a stem cell clinic, Turner and Knoepfler discovered. The state with the most number of clinics was California with 113, followed by Florida with 104, Texas with 71, Colorado with 37, Arizona with 36 and New York with 21. Beverly Hills had the most number of clinics among American cities with 18, and Los Angeles followed with 12. Phoenix had 10 and Scottsdale had 11, both in Arizona. New York City had 14, and San Antonio had 13.
The researchers were unclear on why the clusters of these clinics appeared where they did, but they plan to include this in future studies. The suggestion is that there may be more clinics in urban areas with more people, thus more potential customers. Another theory could be that these clinics are more likely to operate in places where alternative medical approaches are more readily accepted, and where patients are more receptive to procedures that claim to heal. It may also be possible that regulations in each local area factors into the location of the clinics.
Around 80% of the stem cell clinics advertised services that used stem cells taken from the patient’s tissues – fat, but also bone marrow and blood. Some therapies say they use a combination of these cells, according to the study.
The other 20% of clinics offered treatments involving stem cells from other sources, such as amniotic fluid, placental tissue or umbilical cords. The researchers noted that the exact source of these stem cells was not apparent.
Turner and Knoepfler also found a few clinics that advertised treatments using “embryonic stem cells” or “induced pluripotent stem cells,” which are supposedly adult cells remade to become embryonic-like. The companies were not clear on whether the cells were customized for each patient, nor was information given on whether the cells would come from the patient or a donor.
At the extreme end of the list, two clinics claimed to use “bovine amniotic cells,” or stem cells taken from the amniotic fluid of cows.
If these clinics are to be believed, stem cells can fix all medical problems. The companies claim on their websites to treat orthopedic and sports injuries most of all, including muscle and joint wear and tear. General “pain” was another common problem stem cell clinics often treated.
Some clinics said they used stem cells in cosmetic procedures such as breast augmentation and wellness improvements that supposedly enhance sexual function.
The stem cells were also being promoted for more serious health conditions such as heart disease, immune system disorders, lung disease, spinal cord injuries, neurological conditions such as Alzheimer’s, Parkinson’s disease and Lou Gehrig’s disease, among many others. In the majority of these cases, the researchers found that “there is no established scientific consensus that proven safe and efficacious stem cell treatments now exist.”
Turner and Knoepfler were especially concerned with stem cell clinics that targeted parents of children with autism, cerebral palsy and muscular dystrophy. They wrote, “This kind of advertising reveals another tangled knot of ethical and legal concerns,” because the recipients of these questionable treatments are not the ones making the decisions.
Some clinics acknowledged that their treatments were not FDA-approved, while others stressed that their procedures did not require such approval, the study notes.
While the researchers were careful not to say explicitly that these clinics were violating federal or state laws and regulations, they did say that many of the advertised treatments “that do not appear to fit FDA criteria…there are clear grounds for concern that some of the companies we found are not compliant with federal regulations.”
Patients who already suffer from real medical problems might find themselves in even worse conditions, physically, emotionally and financially, if they agree to undergo such treatments, the researchers add. If those treatments go wrong, they could give a negative reputation to stem cell research as a whole, undermining the legitimate work being done in the field.
The FDA issued a draft document last fall outlining its views on human cells, including stem cells, and their regulation. A few months later, the FDA warned the Irvine Stem Cell Treatment Center that it was not following operating procedures.
Turner said it would take a lot more to make sure patients are protected from these practices. “There is an obvious need for the FDA, FTC (Federal Trade Commission), state medical boards and other regulatory bodies to play a more effective role in regulating the marketplace for stem cell interventions,” he said. Without such regulations, these clinics will continue “to peddle false hope for sizable profits.”
The study was published in the journal Cell Stem Cell.