Autistic children in US receiving unapproved stem cell infusions backed by RFK Jr
Clinics across the US are offering unproven stem cell treatments for autistic children, with support from Health Secretary Robert F. Kennedy Jr., despite a lack of scientific evidence and FDA warnings about risks.
Scientists warn that unapproved and potentially harmful stem cell treatments for autistic children are proliferating across the United States, actively encouraged by Health Secretary Robert F. Kennedy Jr. Clinics in Florida, Texas, and other states market so-called regenerative medicine to families with autistic children who have intensive care needs. The procedure, which can involve sedating the child with ketamine and injecting millions of stem cells intravenously, costs up to $20,000 per treatment, and families are often advised to return for regular top-ups.
Despite promises of dramatic improvements in speech and social abilities, there is no scientific evidence that the therapy works. The most comprehensive clinical trial to date, a placebo-controlled study at Duke University, found insignificant benefits for most of the 180 children tested. The US Food and Drug Administration (FDA) directly cautions parents that if they are offered stem cell treatments outside an approved clinical trial, they are likely being deceived and offered an illegal product. In 2021, the FDA reported complications including blindness, tumor formation, and infections from unapproved umbilical cord stem cell products.
Since becoming Health and Human Services Secretary under the Trump administration, Kennedy has cut $31 million in autism research, dismissed scientific advisers, and endorsed alternative health providers. He appeared via video link at summits organized by Autism Health, a leading advocate for stem cell infusions. At those events, providers like Mike Chan, a Malaysian physician, presented a protocol involving injecting autistic children with stem cells from slaughtered sheep and rabbits.
New entrants include Better Stem, a Miami-based company that claims to operate under the federal "Right to Try" law. However, legal experts note that law applies only to terminally ill patients, not to autism. Families like Taylor from Utah, who plans to spend $12,500 on a stem cell infusion for her non-speaking four-year-old son, say they feel compelled to try despite criticism from relatives and the lack of evidence.
