Children with autism in the US are being given stem cell injections, although their effectiveness has not been proven.

Children with autism (some as young as 18 months) are being injected with human stem cells derived from umbilical cord blood. These treatments are not yet approved or proven effective and may pose risks, writes The Guardian.

Scientists warn that such practices are rapidly spreading across the United States, and this is happening with the active support of the Secretary of Health and Human Services, Robert F. Kennedy Jr.

Clinics in Florida, Texas, and other states are offering families with children with severe autism services under the label of "regenerative medicine." Parents who have chosen these procedures express both hope and anxiety about a therapy that is increasingly being used in the United States.

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The procedure may involve injecting the child with ketamine to sedate them, followed by intravenous infusions of millions of stem cells. A single procedure can cost up to $20,000. Families are often advised to repeat these infusions regularly.

Clinics actively convince parents that high doses of cord blood stem cells can significantly improve a child's speech and communication skills, or reduce aggressive and self-destructive behavior. However, there is no scientific evidence to support the effectiveness of such methods. The largest clinical trial on this topic, conducted at Duke University using a placebo, found that most of the 180 children showed only minor improvements.

The U.S. Food and Drug Administration (FDA) clearly warns that if you are offered stem cell therapy outside of an approved clinical trial, “you are likely being misled and offered a product illegally.”

Although a Duke University study found that there are few serious risks when infusions are performed correctly, authorities continue to point out the dangers of poorly regulated procedures. As recently as 2021, the FDA reported cases of complications following the use of cord blood stem cells and other unapproved products, including "vision loss, tumor formation, infections, and other complications."

During his 16 months as head of the Department of Health and Human Services in the Donald Trump administration, Kennedy fired thousands of federal health care workers, removed longtime scientific advisers, cut $31 million in funding for autism research, and tried to reduce the list of recommended childhood vaccinations.

At the same time, he supported alternative healthcare providers seeking to fill the vacant niche. Kennedy spoke via videoconference at the first two annual summits in San Diego, initiated by Autism Health, one of the key organizations promoting stem cell infusions for children with autism.

At last year's summit, he declared, "Your problem is no longer on the fringes." And at a meeting in April of this year, he promised to "create opportunities throughout life" and collaborate with stem cell providers "to develop solutions together."

Among these suppliers was Malaysian doctor Mike Chan. At the summit, he presented a protocol he uses in his Bangkok clinic: high doses of stem cells derived from the tissue of slaughtered sheep and rabbits are injected into the buttocks of children with autism.

"Man is an animal, the most intelligent animal. There are hundreds of medicines of animal origin," Chan wrote.

Kennedy called San Diego summit organizer Tracy Slepcevic "a good friend." In January, he appointed her to the restructured Autism Steering Committee, which guides federally funded research.

Slepcevic is the mother of a child with autism and an advocate for alternative treatments, including stem cell infusions. Next week, she will speak at the ReAwaken America event in Tulsa alongside Eric Trump and Del Bigtree, a prominent anti-vaccine activist who served as communications director for Kennedy's 2024 presidential campaign.

At the summit in San Diego, Slepcevic presented a new experiment: 120 children with autism will be injected with umbilical cord blood stem cells. The project will begin next month in collaboration with a large clinic in Tijuana, Mexico, where regulations in this area are traditionally more lenient than in the United States.

Ed Clay, a former MMA fighter and founder of the Cellular Performance Institute in Tijuana, stated that the clinical trial will be free for families and fully licensed by Cofepris, Mexico's federal regulator. He said the project is conceived as a full-fledged clinical trial involving neurologists and pediatricians, and his company will invest approximately $2 million.

He added that his team includes "21 postdoctoral scientists and 42 physicians, including graduates from Harvard, Yale, MIT and Stanford."

Clay believes that if the results are encouraging, the study could be moved to Nashville and other US cities with full FDA approval.

At the same time, he emphasizes that not all providers of such services adhere to high standards.

"Our main competitors now are scammers and the numerous fly-by-night clinics operating in this field," he said.

Kennedy stated that he didn't want the alternative medicine market to turn into a "Wild West." However, he acknowledged that opening up the market would inevitably lead to the emergence of "charlatans and people with poor results," and that it would be impossible to completely prevent this.

Among the companies actively entering the market for services for children with autism is Miami-based Better Stem, run by Grace Murphy. She describes herself as an entrepreneur; her projects include a tequila brand, Biatch, "created with women's tastes in mind," and a Miami clinic offering stem cell infusions to combat hair loss and erectile dysfunction.

Two months ago, she began offering cord blood stem cell infusions for children with autism. An initial consultation costs $300, and a single procedure costs up to $15,000.

Better Stem claims to be the first company in the US to offer "legal access" to such treatments under the Right to Try Act, signed into law by Donald Trump in 2018. The clinic argues that this law allows the use of unapproved drugs to treat incurable conditions such as autism.

In reality, the law's scope is limited to patients with terminal illnesses and life-threatening conditions. Autism does not fall under this definition.

"Technically, the federal Right to Try law applies to terminal illnesses and does not apply to conditions that are not life-threatening, even if they are not treated," explained Jeff Cohen, a health law expert at Florida Healthcare Law Firm.

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Among the families opting for such procedures are Taylor and her four-year-old son, Ollie, from Utah. At the end of the month, they will travel to Florida, where the boy, who is nonverbal and has severe autism, will undergo a stem cell infusion.

The procedure will cost $12,500. Taylor raised the money largely through donations from family and friends. She wants people to understand "the burden these children carry in a world that isn't designed for them to thrive."

Some relatives criticized her for choosing alternative treatments. But she believes she must try.

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