The Financial Times of London: An FT investigation has found a thriving market for stem cell therapies in the US promising longer, healthier lives. Experts say such claims are dangerous
Dr Heidi Regenass’s voice was warm and reassuring. The patient she was talking to had painful arthritic knees and Regenass had a plan to “regenerate” them in “the most natural possible way”.
The answer, she explained, lay in stem cells — master cells in the body that have the potential to self-renew and transform into other cell types. “Stem cells are fabulous,” she said to the FT reporter posing as a patient. “Coming from a newborn baby . . . [they can be] sent all over your body.”
Regenass, a physician at the time working at Chara Health clinic in Los Angeles, described how stem cells extracted from donated umbilical cords and placentas could heal tissue and reduce inflammation.
To achieve “the very best result”, she suggested injecting them directly into the knee and intravenously into the bloodstream. The therapy would cost $18,450.
Regenass did not mention that the treatment is scientifically unproven and its sale is illegal under federal law. Nor did she mention that the owner of Chara Health had twice received warnings from the US Food and Drug Administration (FDA) for marketing the unapproved new drugs. The latest reprimand, from last year, also noted several manufacturing violations found by FDA inspectors, including missing donor eligibility records and expired products relabelled as in date.
Instead, Regenass breezed past a question about risks. “There’s always a risk of potentially infection, bleeding, but these products are very, very carefully screened so these chances are very, very minimal,” she said. An administrator later emailed a list of dozens of conditions the clinic claimed stem cells could benefit, from autism to diabetes and erectile dysfunction.
Since the 1950s, medicine has utilised stem cells’ regenerative qualities in treatments such as bone marrow transplants and skin grafts. Scientists are examining their potential effectiveness for conditions from Parkinson’s disease to heart problems. But despite encouraging breakthroughs in specific ailments, these other therapeutic uses remain largely hypothetical, confined to research and clinical trials.
In the US, however, a growing market of manufacturers and practitioners is selling empty promises about stem cell products directly to the American public. Billed as the ticket to longer life and a remedy for chronic conditions, the therapies have spread from the preserve of the super-wealthy exploring longevity treatments overseas to domestic high street clinics drawing in salaried workers.
It is a marketplace populated by pseudoscientific claims, spurious products and disgraced doctors seemingly impervious to the threat of federal enforcement. An FT investigation of clinics that have attracted FDA scrutiny found that many were flouting the regulator’s warnings, using a smokescreen of new websites, euphemistic marketing, misleading claims and tongue-in-cheek compliance while continuing to operate much as before.
According to studies by Leigh Turner, director of the Center for Health Ethics at the University of California, Irvine, the handful of clinics offering unproven stem cell therapies in the late 2000s had grown to nearly 600 by 2016 and more than 2,700 in 2021. Turner has not yet published more recent data but says “there has been marketplace growth despite an increase in regulatory activity.”
Experts say the situation is likely to worsen under US health secretary Robert F Kennedy Jr. He has said a stem cell treatment in Antigua “enormously” helped him and pledged to end the FDA’s “war” against alternative medicines, including “the war on stem cells”. Widely followed figures including Joe Rogan and Kim Kardashian have also raised the treatments’ profile, publicly praising procedures in Mexico and Panama, where licensed clinics can lawfully perform stem cell therapies.
“This is a major public health problem,” says Sean Morrison, former president of the International Society for Stem Cell Research (ISSCR). “Not only are [providers] very commonly marketing things that have no potential to benefit the patients, but they do have a very real potential to harm people.”
Read the full story: The cowboy clinics selling unproven longevity treatments (FT)