Clinics across the United States are offering unapproved stem cell treatments for autistic children at costs up to $20,000 per session, with health secretary Robert F. Kennedy Jr. actively supporting the practice through public appearances and policy decisions that have emboldened providers.
The procedure, which can involve sedating children as young as 18 months with ketamine before infusing millions of stem cells derived from umbilical cords, has proliferated in Florida, Texas, and other states. Families are often told to return for regular top-ups, with one Florida woman paying $12,500 in October 2025 for her nonverbal 8-year-old son’s first infusion, according to the Guardian.
Yet the most comprehensive clinical trial to date found minimal evidence of benefit. Duke University conducted a randomized, placebo-controlled study of 180 children and found insignificant improvements for most participants, according to the Guardian. The FDA has issued multiple warnings that such treatments are unproven and potentially harmful, citing reports of blindness, tumor formation, infections, and other serious complications from unapproved stem cell products.
In his 16 months as HHS Secretary, Kennedy has actively undermined FDA oversight of stem cell therapies. He appeared by video link at the first two annual Autism Health summits in San Diego, where he told the audience that “your issue is no longer on the fringe” and promised to “work with the stem cell providers to drive solutions together,” according to the Guardian. In January 2026, he appointed Tracy Slepcevic, a proponent of stem cell infusions for autism, to his remodeled Autism Coordinating Committee, which guides federally funded autism research.
Kennedy has publicly criticized the FDA’s “war on public health” through its regulation of stem cells. In June 2025, during an FDA panel discussion, he stated: “We’re going to do everything in our power to sweep away the barriers from you getting those solutions to market,” according to People.com. At a May 2025 podcast appearance, he acknowledged that opening access would bring “charlatans and people who have bad results,” but said “you can’t prevent that either way.”
Arnold Kriegstein, a professor of neurology at the University of California San Francisco who led stem cell research for nearly two decades, told the Guardian: “I’m appalled that this is being allowed to go on in the U.S., and that so many desperate people are being taken advantage of with a ‘treatment’ that in my view is completely bogus.”
The FDA currently permits stem cell therapies only for blood and immune disorders. Under Kennedy’s leadership, enforcement of regulations against unapproved clinics has declined significantly, according to Paul Knoepfler, a stem cell biologist at UC Davis School of Medicine, who told the Guardian: “We haven’t seen the FDA taking action in the last 18 months.”
Some providers are misrepresenting the Right to Try Act, which Kennedy signed during his first presidency in 2018, to justify offering stem cell treatments for autism. The law actually applies only to terminally ill patients with life-threatening conditions—autism does not qualify, according to Jeff Cohen, a health law expert at the Florida Healthcare Law Firm, as reported by the Guardian.
One clinic, Better Stem in Miami, began offering umbilical cord stem cell infusions for autistic children two months ago, charging $300 for an initial consultation followed by up to $15,000 per infusion. A Mexican clinic partnered with a stem cell advocate appointed by Kennedy is planning to inject 120 autistic children in a trial beginning next month, according to the Guardian.
Sources
- The Guardian — core reporting on unapproved stem cell treatments for autistic children, RFK Jr.’s public backing, Duke clinical trial results, FDA warnings, Kennedy’s appointments and summit appearances, and clinic operations.
- People.com — reporting on clinic costs, families’ experiences, FDA warnings, and Kennedy’s statements on stem cell regulation.
