{"text":[[{"start":7.224,"text":"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”."}],[{"start":18.659,"text":"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.”"}],[{"start":36.656,"text":"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."}],[{"start":48.427,"text":"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."}],[{"start":57.91,"text":"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."}],[{"start":87.383,"text":"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."}],[{"start":null,"text":"

"}],[{"start":108.917,"text":"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."}],[{"start":132.6,"text":"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."}],[{"start":154.057,"text":"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."}],[{"start":179.56,"text":"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.”"}],[{"start":204.737,"text":"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."}],[{"start":233.592,"text":"“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.”"}],[{"start":251.138,"text":"At Chara Health, for example, there was one more thing Regenass did not mention. A few months earlier, the California medical board had launched a disciplinary proceeding against her for “repeated negligent acts” in a liposuction and fat transfer procedure. In 2023 and 2025, she was sued for medical malpractice by the families of three women who died after she performed similar operations on them."}],[{"start":273.802,"text":"Regenass has denied any negligence and that her care caused the women’s deaths. One case has been settled, another dismissed and the third is ongoing."}],[{"start":283.44,"text":"Regenass and Chara Health did not respond to a request for comment. The Department of Health and Human Services did not respond to requests for comment on Kennedy’s public statements."}],[{"start":293.52,"text":"Untested science and its dangers"}],[{"start":294.482,"text":"Disentangling well-evidenced science about stem cells from claims that are exaggerated or outright false can be challenging. Chara Health, for example, claims stem cells can “home in to areas needing repair”, “modulate the immune system” and “differentiate into a variety of cell types”."}],[{"start":311.301,"text":"In a broad sense, these statements are true. But the idea that harnessing these benefits is as simple as extracting stem cells and transplanting them where they are needed is false."}],[{"start":321.978,"text":"“Think of cell environments as a tightly controlled and well-balanced ecosystem,” explains Zubin Master, a member of the ISSCR’s public policy committee. Removing a cell from that ecosystem, even briefly, means “it may not behave as it once did”, Master says. “This is why cell replacement therapies are so complex and challenging.”"}],[{"start":null,"text":""}],[{"start":343.44,"text":"A treatment for heart failure being developed in the UK, for example, has taken 20 years of research to reach the final stage of clinical trials. Scientists have induced stem cells from umbilical cord tissue to develop into bone, cartilage and fat cells in the laboratory, but have not demonstrated they can do so in patients."}],[{"start":360.808,"text":"In the US, a peer-reviewed study published this year tested six commercial umbilical cord “stem cell” products and found they were all “virtually devoid of viable cells”, meaning the therapy could not even work in principle. Similar research in 2021, which included Chara Health’s flagship product CharaCore, reached the same conclusion. The clinic, meanwhile, claims the product is “20 per cent” stem cells."}],[{"start":386.16,"text":"Experts’ concerns are not just about efficacy, however. When bone marrow transplants were first developed, patients in the initial clinical trials died. “It literally took decades of work in order to figure out how to deliver the bone marrow transplants safely to patients,” says Morrison, the former ISSCR president. “So why would we think that . . . therapies and products that haven’t been tested in clinical trials are safe?”"}],[{"start":410.852,"text":"Without regulated trials, the scale of harmful incidents caused by unapproved therapies is impossible to determine. But what information has been shared with the FDA suggests they are on the rise. According to an FT analysis of the regulator’s adverse events database, the agency received reports of 17 incidents linked to stem cells or other unapproved human tissue products in 2025, compared with five the year before."}],[{"start":437,"text":"A Pew review of scientific journals, newspapers and other public sources found more than 330 adverse incidents documented between 2004 and 2020, including patients left with life-long disabilities and 20 reported deaths."}],[{"start":451.627,"text":"Many individuals seeking out stem cell therapies are part of the multitrillion-dollar industry pursuing the elusive goal of “longevity”. The treatments are often sold in combination with peptides and other unproven injectables at the forefront of the health-science culture wars. (Chara Health, for example, says its tissue donors have not been vaccinated against Covid-19.)"}],[{"start":472.494,"text":"But the therapies are also increasingly targeted at people hoping to escape suffering, not mortality."}],[{"start":478.667,"text":"When Shane Goddard was a teenager, a spinal cord injury from a dirt bike accident left him with a permanent limp and pain in his right leg. In 2022, the 41-year-old travelled from Tennessee to Giostar clinic in Mexico and paid $15,695 for “140 million” umbilical cord stem cells to be injected into his spine."}],[{"start":499.2,"text":"Shortly afterwards, Goddard developed a high fever and burning pain in his back. “It felt like hot tar was in between my shoulder blades,” he says. Weeks later, Goddard started to lose movement in his fingers and drag his leg “like an animal hit by a car”. A scan revealed an infected abscess was flattening his spinal cord. Doctors told him if they did not perform emergency surgery he could be paralysed by the next morning. Goddard ended up in hospital for six weeks and still can’t use his hands today."}],[{"start":529.622,"text":"“I went and got these stem cells in the hope of getting better and it has made me so much worse,” he says. “That’s what I want to caution people about. Do your research, because I literally almost died.”"}],[{"start":541.2,"text":"Giostar did not respond to a request for comment."}],[{"start":544.4,"text":"Flouting the law"}],[{"start":545.488,"text":"In the US, new drugs and biological products need FDA approval. The agency typically requires clinical trials to demonstrate they are safe and effective. Marketing them without this approval is illegal."}],[{"start":557.037,"text":"In the late 2010s, after years of light-touch oversight, the FDA issued a flurry of warning letters to stem cell companies and publicly pledged a firmer approach to enforcement."}],[{"start":566.721,"text":"“The FDA realised . . . this was getting out of hand,” says Morrison. “The problem was that even when the FDA started being more aggressive . . . they really didn’t have the resources to go after the large numbers of companies that were violating the law.”"}],[{"start":null,"text":""}],[{"start":579.691,"text":"Instead, the regulator and justice department focused on the worst actors. In 2024, a California-based stem cell product manufacturer was sentenced to 36 months in prison for distributing unapproved new drugs. The injectables, made from umbilical cord cells, had been linked to the hospitalisation of 19 people. In 2019, a federal court brought an injunction against a clinic in Florida after three patients who received stem cell products harvested from their own fat went blind."}],[{"start":609.099,"text":"Other actions have been brought by state attorneys-general. Also in 2019, New York attorney-general Letitia James successfully sued a doctor and his Manhattan clinic for fraudulently advertising unproven stem cell treatments. He was ordered to pay $5.1mn in fines and compensation. The Federal Trade Commission has also filed civil suits against individuals and companies for deceptive advertising of stem cell therapies."}],[{"start":636.833,"text":"But these high-profile cases have not had a chilling effect. Of the 25 organisations that have received FDA warning letters for marketing unapproved stem cell products since 2021, the FT found that many appeared to have continued to flout the regulator’s rules — a situation the FDA says it is aware of."}],[{"start":655.457,"text":"“Warning letters and enforcement actions are done to give a signal [in industries] where well-behaving people will tighten up their behaviour, but here you are dealing with a rogue industry,” says Robert Califf, a former FDA commissioner. “This is outside of that.”"}],[{"start":671.234,"text":"Dr Alvaro Skupin, the founder of Mother Stem Institute in Florida, for example, was put on notice by the FDA in September 2024. The year before, Skupin settled a lawsuit brought against him by a woman who claimed that a stem cell treatment he injected into her eyes left her blind. (Skupin denied any wrongdoing.)"}],[{"start":null,"text":""}],[{"start":691.44,"text":"But during a phone consultation with an FT reporter purporting to be a prospective patient, Skupin downplayed the risk of his procedures and made sweeping pseudoscientific claims. Claiming to have a “94 per cent” success rate, he said that extracting a patient’s blood and “burning a laser” would produce “pluripotent stem cells” that could “improve the knees, the tendons, the bones, maybe the prostate” when reinjected."}],[{"start":715.06,"text":"Blood stem cells are not “pluripotent”, a term which describes stem cells that can develop into almost all cell types."}],[{"start":723.2,"text":"“Whatever damage is done to almost any organ. Diabetes also. It will get better,” Skupin continued. He offered the reporter a “Father’s day special” discount and said the treatment could make him feel 10 years younger. As for side effects, he claimed bruising was “the worst that can happen”."}],[{"start":739.082,"text":"Other clinics have taken creative approaches to toeing the regulatory line. In August 2025, the FDA wrote to the Innate Healthcare Institute in Arizona, warning it to stop marketing unapproved stem cell therapies. The letter highlighted a customer statement on Innate’s website that said: “Stem cell therapy has really helped our son with his autism.”"}],[{"start":760.48,"text":"This week, a video on the website of a family discussing their autistic son did not mention stem cells, instead referring unspecifically to “the Innate Healthcare Institute therapy” he had. But the website does describe the clinic’s “S.T.E.M. approach to care: Safety-first. Transparent. Evidence-informed. Mindful.” The Stem acronym appears above a disclaimer that some services are not FDA-approved."}],[{"start":787.77,"text":"When approached by an FT reporter posing as a patient who has an autistic daughter, a doctor at Innate suggested injecting the “kiddo” with stem cells through an IV and using a nasal spray. “It’s very effective for autism,” she said, adding that the clinic had treated children as young as two before. “We have to be careful about how we market it because of our government in the US . . . It’s not a ‘treatment’,” she said, making air quotes and smiling knowingly. “It’s an experimental option.”"}],[{"start":813.12,"text":"Some practitioners appear so unfazed by federal enforcement that they have even mocked the regulator in public. In 2021, stem cell product manufacturer Eliott Spencer received two FDA warning letters, including for manufacturing violations such as using non-sterile equipment. A few years later, Spencer appeared on an episode of the No BullSh*t, Just BullFit podcast. Sitting on a purple sofa next to two burly hosts dressed in tiger-print leggings, Spencer made repeated tongue-in-cheek references to FDA rules."}],[{"start":848.04,"text":"“Screw you FDA, but basically we know of people that have used our product to treat various cancers,” he said. When asked if he could share any discount codes, he joked: “We’ll come up with some good discount codes involving the FDA.”"}],[{"start":862.5,"text":"Skupin, Innate Healthcare Institute and Spencer did not respond to a request for comment."}],[{"start":null,"text":""}],[{"start":863,"text":"Informed decisions"}],[{"start":865.771,"text":"The legal landscape for unapproved stem cell therapies has been complicated in recent years by new state laws at loggerheads with federal regulation."}],[{"start":875.209,"text":"Since 2024, states such as Florida, Utah and Wyoming have introduced bills that allow physicians to perform unapproved stem cell therapies under certain caveats. Local laws cannot usurp federal enforcement, but Master, of the ISSCR’s public policy committee, says he has seen a “fair degree of confusion” among the public. “It’s confusing when in one state they see ‘buyer beware’ and in another state, not,” he says."}],[{"start":903.54,"text":"Some clinics are exploiting this complicated environment. Chara Health, for example, claims in marketing material that its stem cell products are “completely unmanipulated, qualifying them as tissue transplants”, not drugs. That is incorrect, according to warning letters sent by the regulator to the clinic’s founder, Dr Joy Kong, in 2019 and 2025."}],[{"start":924.427,"text":"In a California district court, another clinic successfully ran a similar argument to Kong, claiming the procedures were exempt from federal regulation because the doctors were practising medicine, not manufacturing pharmaceuticals. The decision was later overturned by an appeals court, restoring the FDA’s authority, but experts say the case has nonetheless opened the door to costly legal challenges that hamper enforcement."}],[{"start":null,"text":""}],[{"start":948.846,"text":"“As the FDA, given all the things you have to do, the limited resources that you have, and the risk of taking this all the way to court and losing . . . That’s the thing,” says Califf."}],[{"start":958.896,"text":"The FDA says stem cell therapies are “an active and escalating enforcement priority”. It adds that “protecting patients . . . is a core and enduring part of the agency’s work, regardless of the broader environment”."}],[{"start":970.607,"text":"Some patients say that the decision whether to use stem cell therapies should be theirs, not the government’s."}],[{"start":977.524,"text":"In 2023, Sweta Patel spent $6,000 on a “bogus” stem cell treatment in Utah that had no noticeable effect. But Patel, who lives in chronic pain due to several autoimmune disorders, says other stem cell treatments she has had in the past transformed her symptoms “like night and day”. She thinks the industry has become awash with unethical providers partly because it is forced to exist outside of regulation. “Those of us with rare or misunderstood illnesses are the easiest to exploit,” she says."}],[{"start":1008.006,"text":"Health secretary Kennedy has echoed this argument. He said last year the FDA should not “tell physicians what they can and cannot prescribe” or tell people what drugs they can take. “If you want to take an experimental drug . . . you ought to be able to do that,” he said last year."}],[{"start":null,"text":""}],[{"start":1024.79,"text":"But many experts do not agree. “Individual patients and even their physicians don’t have the time or the expertise or the access to the data that’s necessary to truly make an informed decision about whether an experimental regenerative medicine product actually does have the potential to help,” Morrison of the ISSCR says."}],[{"start":1046.58,"text":"While Califf acknowledges “there’s a flexibility of thinking that is needed here that is not easily handled by the regulatory regime”, he also disputes that the barriers to FDA approval are too high."}],[{"start":1054.403,"text":"“If you want to spend money on an intervention,” he says, “you should only do that if the benefits outweigh the risk. And we completely understand how to determine if the benefits outweigh the risk . . . It’s called an adequate, well-controlled clinical trial.”"}],[{"start":1066.54,"text":"But for now, a crackdown on cowboy clinics seems unlikely. When asked whether the US health secretary would be a deterrent to enforcement efforts, Califf said: “RFK is the greatest champion for unproven and perhaps dangerous treatments in the US."}],[{"start":1080.88,"text":"“The FDA reports to RFK. So that’s sort of a rhetorical question.”"}],[{"start":1090.46,"text":""}]],"url":"https://audio.ftcn.net.cn/album/a_1787923051_8647.mp3"}