Beverly Hills, New York, Los Angeles, San Antonio, Austin, and Phoenix are “hotspots” for unproven stem cell treatments, medical investigators reported on Thursday. The researchers identified a surprisingly large number — 570 — of medical clinics offering the unproven treatments in the U.S.
Before this survey, most people had associated dubious stem cell treatments with “medical tourism” done in clinics outside of the U.S. But by looking at stem cell clinic advertising across the country, the new study found that adult stem cells — whether collected from body fat, bone marrow, or umbilical cord blood — are being peddled as cures for everything from sports injuries to baldness to dementia. There is scant evidence that these treatments actually work, aside from ardent patient testimonials and publicity from sports stars, starting with Major League Baseball pitcher Bartolo Colon’s recovery from an elbow injury in 2011. Treatment costs can run to tens of thousands of dollars.
“I was very surprised by the numbers,” study co-author Paul Knoepfler of the University of California, Davis, told BuzzFeed News. “There are stem cell clinics in just about every U.S. state.”
Stem cells are the starter cells for all kinds of other tissues, from blood to bone to brain, and are under intense investigation in hundreds of clinical trials as disease treatments, where the cells are usually infused or injected into sites of injury or disease. But for now, the only federally approved stem cell treatments are bone marrow transplants and a cord blood treatment for blood disorders, and the FDA has repeatedly warned of a “potential safety risk” of unproven ones.
Nevertheless, U.S. stem cell clinics are flourishing, the study shows, spurred by reports of celebrities such as retired quarterback Peyton Manning and former Texas governor Rick Perry seeking the treatments. They largely escape FDA regulation because clinics most often inject the patient's own cells into their body, without much modification.
The majority of the clinics, 61%, rely on fat removed by liposuction from patients to provide the stem cells for treatments, the study finds, and nearly half, 48%, offered bone marrow cell treatments. Very few clinics advertised more exotic embryonic stem cell treatments; two offered injections of amniotic cow cells into patients.
“In theory, stem cells may advance the treatment of many other diseases or conditions,” FDA spokesperson Andrea Fischer told BuzzFeed News by email. “The FDA is 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 FDA plans two public meetings in September on ways that stem cell clinics might prove their treatments are effective, and will issue final stem cell treatment advertising guidelines later this year.
In 2012, the agency issued a warning about stem cell clinics after the arrest of three “scammers” who made $1.5 million selling cord blood cells to people with incurable diseases. The agency also sent a warning letter last year to a Florida doctor selling stem cells to treat autism, Parkinson’s disease, pulmonary fibrosis, chronic obstructive pulmonary disease, multiple sclerosis, cerebral palsy, and amyotrophic lateral sclerosis.
By far, the study’s search of online marketing terms for various adult stem cell treatments shows that orthopaedic and pain injuries are the most marketed treatments. Typically orthopedic clinics might offer the treatments along with other services, bioethicist Leigh Turner of the University of Minnesota, the study’s other author, told BuzzFeed News. Cosmetic surgeons, who already do liposuction, might also offer to return stem cells purified from removed fat for cosmetic procedures, another popular category.
“Where the focus should be for regulatory action is the clinics that make the most extreme claims — for 30 to 40 diseases all in one place,” Turner said. “Those ones look the most dodgy.”
Also worrisome, he said, the cells are sometimes marketed to treat kids with autism and muscular dystrophy, seen in 33 clinics, or the elderly with Alzheimer’s, seen in 27 clinics, where the patients might not be the ones deciding whether to take the risk of the treatments.
“This industry has the potential to have a very big, mostly negative impact,” Knoepfler said. Even if each clinic is seeing fewer than 200 patients a year, “then that is more than 100,000 people getting largely unproven stem cell therapies, which makes this a huge deal.”