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U.S. clinics in Florida, Texas and other states are providing unapproved umbilical cord stem cell infusions to autistic children as young as 18 months. The treatments cost up to $20,000 per session and lack FDA approval. Health and Human Services Secretary Robert F. Kennedy Jr. has appeared at summits promoting the approach.
The GuardianAutistic children as young as 18 months are receiving intravenous infusions of human stem cells derived from umbilical cords at clinics in Florida, Texas and other states. The procedures are not approved by the U.S. Food and Drug Administration and cost families as much as $20,000 per session.
Clinics market the infusions as regenerative medicine that may improve speech, social interaction or reduce aggressive behavior. Parents are often advised to schedule repeated treatments.
The FDA states that stem cell treatments offered outside approved clinical trials are likely illegal. In 2021 the agency reported receiving accounts of blindness, tumor formation and infections after use of similar unapproved umbilical cord products.
A placebo-controlled trial conducted by Duke University involving 180 children found no significant benefit for most participants. The agency continues to warn of safety risks when such products are administered outside regulated settings.
Kennedy Jr. has spoken at two annual summits organized by Autism Health in San Diego. At the 2025 event he told attendees their issue was no longer on the fringe; at the April 2026 gathering he pledged to work with stem cell providers. Kennedy appointed Tracy Slepcevic, organizer of the summits and mother of an autistic son, to the Autism Coordinating Committee in January.
Slepcevic has scheduled a new trial injecting 120 children with umbilical cord stem cells beginning next month at a clinic in Tijuana, Mexico.
Ed Clay, founder of the Cellular Performance Institute in Tijuana, said the Mexico trial will be free to families, licensed by Mexican authorities, and backed by $2 million in company funding. He stated the clinic employs 21 PhD scientists and 42 medical doctors.
Better Stem, a Miami company, began offering the infusions two months ago under the federal Right to Try Act. Health law expert Jeff Cohen said the statute applies only to patients with terminal, life-threatening conditions, which autism does not meet.
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