Landyn Holdren, an eight-year-old autistic child with high support needs and who is nonspeaking, often engages in self-harming behavior when distressed, according to his mother, Christy Holdren. Later this month, she will spend $15,000 on an unapproved stem cell treatment in hopes it will help him.
The family underwent the first round of treatment last October at a Florida stem cell clinic, costing $12,500. The procedure lacks approval from the Food and Drug Administration (FDA), and scientists say there is little evidence it works for autism, raising concerns that desperate families are being sold false hope.
As stem cell clinics multiply across America, they have found an influential ally in US Health Secretary Robert F Kennedy Jr. Holdren acknowledges there is no cure for autism but feels compelled to do everything possible for her child.
“He actually looks at us and not through us, and that's huge for us,” she said of the small but significant changes she observed after Landyn's first infusion. “We can cut his hair without him freaking out. That may sound little, but when you have to wrangle an alligator to clip his nails, that's big things.”
Seven months later, Landyn's aggressive and self-harming behavior is worsening. Despite the cost, which forced Holdren to take out a loan against her retirement savings, she is preparing for a second stem cell dose.
A ‘completely bogus’ treatment
The Holdrens are not alone. Across the US, children with autism as young as 18 months are receiving unapproved stem cell treatments at clinics in Florida, Texas, and elsewhere. These procedures often involve intravenous doses of millions of stem cells derived from human umbilical cords, with children sedated during infusion.
In some cases, doctors selling these treatments lack expertise in autism or child development, with physicians from unrelated specialties like plastic surgery entering the booming stem cell sector. Up to now, Americans seeking unapproved therapies often looked abroad, fueling multibillion-dollar “stem cell tourism” in places like Mexico and Panama.
Now, the practice is gaining strength within the US, and there are fears that under Kennedy's leadership, the FDA may loosen its rigorous regulation. Paul Knoepfler, a stem cell biologist at UC Davis School of Medicine, has detected a slump in enforcement activity under Kennedy and is concerned about a policy shift.
“We haven't seen the FDA taking action in the last 18 months. I think we're going to see big change coming from the FDA very soon, backing off oversight of birth-related stem cells,” he said.
Arnold Kriegstein, professor of neurology at UC San Francisco, expressed concern about the spread of expensive and unproven interventions on vulnerable children. “I'm appalled that this is being allowed to go on in the US, and that so many desperate people are being taken advantage of with a ‘treatment' that in my view is completely bogus.”
Stem cell science and autism
The FDA has only approved stem cells for narrow uses like bone marrow transplants. However, the technique is attracting attention for various treatments. Stem cells are master cells that can renew themselves and develop into specialized cells, showing promise for diseases like Parkinson's and type 2 diabetes.
But autism is a heterogeneous neurodevelopmental condition, not a cell-based complication, making treatment development challenging. Kennedy has not publicly moved to relax FDA restrictions on stem cell therapies but has focused on cutting autism research, attacking evidence-based science, and championing alternative medicine providers.
Early in his tenure, Kennedy invited Dr Chadwick Prodromos, an orthopaedic surgeon offering umbilical stem cells, to a roundtable to discuss diluting federal regulations. Prodromos had treated Kennedy personally in Antigua for his voice condition. Prodromos now offers umbilical cord stem cell infusions to autistic children from US clinics in Naples, Florida, and Dallas, Texas, claiming 85% of patients have had “meaningful improvement.”
Fiona O'Leary, a campaigner against pseudoscience, contacted Prodromos's institute and was told families no longer need to travel abroad. The employee cited a Florida law allowing stem cell treatments for orthopaedics, wound care, or pain management, but autism is not covered. Jeff Cohen, a health law expert, confirmed the law is specific to those three purposes.
O'Leary called the situation upsetting: “Kennedy is undoing so much hard work to hold back the misinformation. Autistic kids are being experimented on. Families are spending huge amounts, and losing everything.”
Prodromos defended his practice, stating he offers stem cells under the “pain management” category for autistic patients with documented headaches. He described his offering as “evidence-backed treatment which is very safe” and not exploitation.
The Tijuana experiment
Under Kennedy, advocates of fringe autism treatments are gaining influence. In January, he appointed Tracy Slepcevic, a mother of an autistic child and supporter of alternative therapies, to a federal committee on autism research. Slepcevic, who shares Kennedy's vaccine skepticism, has taken her son for unproven treatments including chelation therapy, which the FDA warns can cause serious side effects.
Slepcevic also took her son to Ukraine for stem cell therapy. In April, she staged an Autism Health Summit in San Diego, with Kennedy as the star speaker. At the summit, she announced a “pioneering” experiment with a clinic in Tijuana, Mexico, involving umbilical stem cells for 120 children aged 7 to 15 with autism. The trial, under Mexican oversight, will test safety and efficacy over 12 months, with hopes to expand to the US.
The clinic's owner, Ed Clay, a former boxer, agreed to the trial despite having no experience with autism. He emphasized that his full-service hospital is not like unscrupulous clinics, calling claims of stem cells as a cure-all “ridiculous.”
Another presenter at the summit was Mike Chan, a Malaysian doctor who claims to reverse biological age with stem cells. His clinic in Thailand markets autism treatment packages for $13,800, using fetal stem cells from merino sheep. Staff described restraining children during injections, but Chan denied this, saying he never forces treatment.
Desperate families
Parents drawn to stem cell treatments often feel abandoned by the US system. A mother of a three-year-old with severe autism, who asked to remain anonymous, has spent $20,000 out-of-pocket and plans to spend more for unapproved stem cells. She criticized the lack of government assistance and insurance coverage.
Katelyn Cook, from Erie, Pennsylvania, found stem cell treatment through TikTok. She took her son Colston to North Florida Stem Cells clinic, where he received umbilical stem cells. Cook reported improvements in his behavior and presence, but after six months, aggression returned, prompting another visit. The first dose cost $8,000, and she will pay the same again.
“I would spend anything to give him a better chance at life,” she said.
Landyn's mother, Holdren, remains cautious. She worries about families who see the treatment as miraculous and fears unscrupulous providers. She found comfort in knowing the clinic's founder, Eric Weiss, is a parent of an autistic child. Weiss, a plastic surgeon, changed his practice to focus on stem cell therapies, claiming 65-70% of autistic children respond positively.
However, a larger, more rigorous Duke University trial in 2020 found no improvement in socialization skills or autism symptoms from umbilical cord stem cells. A similar study by Sutter Health reached the same conclusion.
Scientists remain concerned about potential dangers, with a Pew survey recording 360 cases of side effects from unapproved clinics, including life-threatening infections. Additionally, families may drop evidence-based therapies for stem cells, causing harm.
Under the Biden administration, the FDA issued warning letters to clinics, stating stem cell products are unapproved drugs. The agency cautioned that “you are likely being deceived and offered a product illegally.”
Kennedy now appears intent on dismantling this regulatory regime. He told a podcaster he doesn't want a “wild west” but also said “you can't prevent” charlatans. Knoepfler disagreed: “I would have hoped the health secretary would say he is going to do everything in his power to go after the charlatans and protect the kids.”
