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Autistic children as young as 18 months old are being injected with human stem cells derived from umbilical cords in unapproved, unproven and potentially harmful “treatments” that scientists warn are proliferating across the US under the active encouragement of the US health secretary, Robert F Kennedy Jr.

Clinics in Florida, Texas and other states are selling what they bill as “regenerative medicine” to families with autistic children who have intensive care needs. Parents who have taken their children through the process talked to the Guardian about their hopes and fears for a therapy that appears to be gaining ground in the US.

The procedure, which can involve the child being sedated with ketamine before receiving intravenous doses of millions of stem cells, costs up to $20,000 each treatment. Families are often advised to return for regular top-ups.

Profoundly stressed parents are being wooed to the clinics with promises that a high-dose infusion of umbilical cord stem cells can lead to dramatic improvements in their children’s ability to speak, socialise, or avoid aggressive or self-harming behaviour. Yet there is no scientific evidence that the procedure works – the most comprehensive clinical trial staged so far, a placebo experiment conducted by 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 being offered stem cell treatments outside an approved clinical trial, “you are likely being deceived and offered a product illegally”.

Though the Duke trial found minimal safety concerns with properly administered stem cell infusions, authorities continue to highlight the potential risks of under-regulated therapies.

The FDA warned in 2021 that it had received reports of complications following applications of umbilical cord stem cells and other related unapproved products leading to “blindness, tumor formation, infections and more”.

In his 16 months as the secretary of the Department of Health and Human Services within the Trump administration, Kennedy has undercut established scientific endeavors. He has fired thousands of federal health officials, dismissed longstanding scientific advisers, defunded $31m in autism-related research and attempted to shrink the recommended list of childhood vaccinations.

At the same time, largely unnoticed, he has given his backing to alternative health providers moving to fill the gap. Kennedy appeared by video link at the first two annual summits held in San Diego by Autism Health, a leading advocate of stem cell infusions for autistic kids.

At the summit last year, he told the audience that “your issue is no longer on the fringe”. At this year’s gathering in April, he promised to “create opportunities that extend across a lifetime” and to work with the stem cell providers “to drive solutions together”.

Those providers included Mike Chan, a Malaysian physician who presented the San Diego summit with a protocol that he practices from his clinic in Bangkok. It involves injecting autistic children in the buttocks with high doses of stem cells extracted from slaughtered sheep and rabbits.

“Man himself is an animal, the most intelligent animal. There are hundreds of drugs from animals,” Chan told the Guardian in an email exchange.

Kennedy described the organiser of the San Diego summit, Tracy Slepcevic, as a “good friend”. In January, the health secretary appointed her to his remodelled Autism Coordinating Committee, which guides federally funded autism research.

Slepcevic is the mother of an autistic son and a proponent of alternative therapies for autism including stem cell infusions. She will be appearing alongside Eric Trump and Del Bigtree, the influential anti-vaxxer who was communications director of Kennedy’s 2024 presidential campaign, on stage at the Christian nationalist ReAwaken America reunion in Tulsa next week.

Slepcevic unveiled at the San Diego summit a new experiment that involves injecting 120 autistic children with umbilical cord stem cells. The effort will begin next month in partnership with a major clinic in Tijuana in Mexico, a country which has historically taken a looser approach to stem cell regulation than the US.

Slepcevic has not responded to a request for comment from the Guardian.

Ed Clay, a former MMA fighter who founded the Cellular Performance Institute (CPI) in Tijuana, told the Guardian that the clinical trial would be free to families and would be fully licensed under the Mexican federal health authority, Cofepris.

He said he had devised the exercise as a clinical trial with expert neurologists and paediatricians serving as investigators in the full-service hospital his company runs in Mexico, with the CPI investing about $2m to conduct it.

His team includes, he said, “21 PhD scientists and 42 medical doctors, including PhDs from institutions such as Harvard, Yale, MIT and Stanford”.

Clay said the clinical trial could be imported at later stages to Nashville and other US sites under full FDA licensing if early results in Mexico were promising.

While the CPI prides itself at using state-of-the-art medical technology, other stem cell providers now moving into autism treatment do not hold such standards. Clay said: “I would say our biggest competitor right now for CPI is the scammer and the many fly-by-night clinics operating in this space.”

Kennedy has said that he does not want to see a “wild west” of alternative therapies developing in the US. Yet in the same breath, he conceded that opening up the country to such providers will lead to “charlatans and people who have bad results, but ultimately you can’t prevent that”. The Guardian has contacted the US health department and the FDA but did not receive a reply.

Among the newly emboldened raft of stem cell providers targeting autistic kids is Better Stem, a Miami-based company run by Greice Murphy. She describes herself as an entrepreneur whose other ventures include the suggestively named “Biatch”, a range of “artfully crafted tequilas made for the woman’s palate”, and a Miami stem cell clinic offering infusions to address hair loss and erectile dysfunction. The Guardian contacted Murphy for comment, but she did not respond prior to publication.

Two months ago, she moved into the business of offering umbilical cord stem cell infusions for autistic children. Families are charged $300 for an initial consultation, followed by up to $15,000 per infusion.

Better Stem claims to be the first company in the US offering “legal, compliant access” to stem cell therapies under the “right-to-try” law signed by Donald Trump in 2018 during his first presidency. The clinic tells prospective clients that the legislation allows patients with a debilitating condition that has no cure, such as autism, to be treated with unapproved drugs.

In fact, the Right to Try Act is specifically limited to patients who are terminally ill and have been diagnosed with a “life-threatening disease or condition”. Autism does not fall under that definition.

“Technically speaking, the federal Right to Try Act covers terminal diseases and is not applicable to non life-threatening conditions even if they have no cure,” said Jeff Cohen, an expert in health law at the Florida Healthcare Law Firm.

Among the families who are being drawn to stem cell therapies are Taylor and her four-year-old son, Ollie, from Utah. At the end of this month, they will travel to Florida for an infusion of umbilical stem cells for Ollie, who is non-speaking and has been diagnosed with autism with high support needs.

The procedure will cost Taylor $12,500, which she has raised largely through donations from family and friends. She told the Guardian that her heart’s wish was that people would come to understand “the weight these children carry in a world that was not designed to help them thrive”.

She has had family members chide her for seeking alternative therapies, which they have described as “a little bit crazy”.

Her view, though, is that “I have to at least try. For those who pass judgment, I hope they come to understand the lengths we must go, simply because no one else will.”