Autistic children injected with unapproved stem cell treatments supported by RFK Jr

Clinics selling costly treatments

U.S. clinics are marketing unapproved stem cell infusions to families of autistic children, according to reporting published by The Guardian on June 12, 2026.

The investigation says some providers are charging as much as $20,000 for a single treatment, and in some cases families are being told to return for repeat infusions.

The children described in the report are as young as 18 months. The treatments involve umbilical-cord-derived stem cells and are being offered in clinics in Florida, Texas and elsewhere.

Weak evidence and medical risk

The reporting says there is no scientific evidence that the treatment works for autism.

It cites a placebo-controlled Duke University study of 180 children that found insignificant benefits for most participants.

The Guardian also said the U.S. Food and Drug Administration has warned that stem cell products sold outside an approved clinical trial are unapproved and illegal to market that way.

The report says the FDA warned in 2021 of reports including blindness, tumor formation, infections and other complications tied to unapproved umbilical-cord stem cell products.

That creates both a financial and medical risk for families: large out-of-pocket bills for a treatment that has not been shown to help, and exposure to possible harm from biologic products regulators say should not be sold this way.

Kennedy's role

The reporting places the market in the context of Health Secretary Robert F. Kennedy Jr.'s public support for autism-linked stem cell advocates.

According to The Guardian, Kennedy appeared by video at Autism Health summits and told one audience that autism was no longer "on the fringe."

He later said he would work with stem cell providers to "drive solutions together," the report says.

The story also says Kennedy appointed Tracy Slepcevic to the federal Autism Coordinating Committee in January 2026.

That matters because public support from a senior federal official can lend credibility and momentum to a treatment market that regulators say is unlawful outside properly approved clinical trials.

How the market is expanding

A companion Guardian investigation said some clinics are trying to use legal loopholes, describing the treatments as regenerative medicine or invoking right-to-try language.

Experts quoted in the reporting said autism does not meet the legal definition of a terminal condition, so those arguments do not make the treatments lawful outside the trial system.

The companion story also said some providers are expanding beyond U.S. clinics, including a planned 120-child stem cell experiment in Tijuana, Mexico.

The report framed the business as a booming market built around families looking for help, even though the best available evidence does not support the treatment claims.

What regulators may do next

The FDA has warned that parents offered these products outside a clinical trial are likely being deceived, according to the same-day Guardian reporting.

A later Guardian live update on June 12 repeated the core findings and the FDA warning, showing the story remained current later in the day.

Open questions now include whether the FDA or Health and Human Services will issue a direct response, whether any clinics or researchers named in the reports will publicly rebut the allegations, and whether the planned Mexico-based trial will actually begin.

For now, the reporting points to a medically risky market with weak evidence, high prices and federal oversight questions that are likely to grow if more clinics move to scale up the treatment.

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