Families of children with autism across the United States are paying for unapproved stem cell treatments that have no proven scientific benefit, according to an investigation by The Guardian also reported by People. Some of the children are as young as 18 months, and clinics in Florida, Texas and other states market the procedures as “regenerative medicine,” despite repeated warnings from the U.S. Food and Drug Administration.
In some cases, children are sedated with ketamine and then given intravenous infusions of millions of stem cells from umbilical cords. Clinics promise gains in speech, social communication, aggression and self-injury, but the strongest clinical trial so far, a Duke University placebo-controlled study of 180 children, found no meaningful benefit for most participants. Each treatment can cost up to $20,000, and some families are pushed toward repeat sessions.
One Florida mother, Christy Holdern, paid $12,500 in October 2025 for treatment for her eight-year-old son Landyn, who has autism and does not speak. She said she does not believe in an autism “cure,” but felt she had to try anything that might help. Seven months later, People reported, Landyn’s aggressive behavior had worsened, yet Holdern still planned to spend another $15,000. Another mother, Taylor from Utah, said she and her four-year-old nonverbal son Ollie were flying to Florida for a $12,500 infusion funded mostly by family and friends.
Experts quoted by The Guardian said the practice is exploitative and unsupported. Arnold Kriegstein of the University of California, San Francisco called it “a basic exploitation” of desperate people. In Israel, Prof. Gal Meiri of Soroka Medical Center said there is still no high-quality evidence to recommend stem cell therapy for autism and warned that the procedures can involve pain, anxiety, side effects and medical risks.
The FDA says stem cell treatments outside approved clinical trials may be illegal and warns that patients are likely being misled. It has also reported complications such as blindness, tumors and infections. The controversy has grown alongside public support from U.S. Health Secretary Robert F. Kennedy Jr., who has backed broader access to experimental treatments, appeared in videos at Autism Health conferences, and in January appointed Tracy Slepcevic, a mother who supports alternative treatments, to an autism coordination committee. The report also said a new trial of 120 autistic children is due to start next month in Mexico, while some clinics and companies, including Better Stem in Miami, continue to charge large sums for unproven care.
