Concerns are growing in the United States over the proliferation of unapproved stem cell treatments being offered to parents of autistic children. These procedures, which involve injecting human stem cells derived from umbilical cords, are being marketed as “regenerative medicine” despite a lack of robust scientific evidence to support their efficacy. Parents, often in desperate circumstances, are reportedly paying up to $20,000 (approximately £16,000) for each treatment session, with some clinics advising regular follow-up infusions.
Reports suggest that children as young as 18 months old are undergoing these treatments, which can involve sedation with ketamine before intravenous administration of millions of stem cells. Clinics in states such as Florida and Texas are promoting these therapies with promises of significant improvements in a child’s ability to speak, socialise, or manage aggressive behaviours. However, the most comprehensive clinical trial conducted to date, a placebo-controlled study by Duke University involving 180 children, found only insignificant benefits for the majority of participants.
The US Food and Drug Administration (FDA) has issued clear warnings against these unapproved therapies, cautioning parents that if they are offered stem cell treatments outside of an approved clinical trial, they are “likely being deceived and offered a product illegally”. In 2021, the FDA reported receiving accounts of serious complications arising from the use of unapproved umbilical cord stem cells and similar products, including instances of “blindness, tumour formation, infections and more”.
Adding to these concerns, Robert F Kennedy Jr, the US health secretary, has reportedly shown support for alternative health providers. During his 16 months in the Trump administration's Department of Health and Human Services, he has been noted for actions such as dismissing federal health officials, defunding autism-related research, and questioning childhood vaccination recommendations. He has also appeared at summits organised by Autism Health, a prominent advocate for stem cell infusions for autistic children, where he spoke of creating opportunities and collaborating with stem cell providers.
The organiser of these summits, Tracy Slepcevic, who is a proponent of alternative autism therapies and mother to an autistic son, was appointed by Kennedy to his remodelled Autism Coordinating Committee. One provider presenting at a San Diego summit, Malaysian physician Mike Chan, reportedly outlined a protocol involving injecting autistic children in the buttocks with stem cells extracted from slaughtered sheep and rabbits, a practice he defends by stating, “Man himself is an animal, the most intelligent animal. There are hundreds of drugs from animals.”
For UK patients and the NHS, it is crucial to understand that such unapproved and unproven treatments are not endorsed by official health bodies. NHS guidelines and NICE recommendations consistently emphasise evidence-based medicine. The NHS does not offer or support stem cell therapies for autism outside of rigorously approved clinical trials. Patients in the UK are always advised to consult their GP or call NHS 111 for any health concerns and to rely on treatments that have undergone thorough scientific scrutiny and regulatory approval.