Health
Jun 12, 2026
RFK Jr. Backs Unapproved Stem‑Cell Treatments for Autistic Children Amid FDA Warnings
Autistic children as young as 18 months are receiving costly, unapproved stem‑cell infusions in U.S…
Autistic children as young as 18 months are being given costly, unapproved stem‑cell infusions in clinics across the US, a practice that has gained the vocal support of Robert F Kennedy Jr, the current U.S. Health and Human Services secretary.Unapproved Stem‑Cell Infusions Target Autistic ChildrenClinics in Florida, Texas and other states market “regenerative medicine” to families of autistic children. The procedure often involves sedation with ketamine followed by intravenous delivery of millions of umbilical‑cord stem cells, sometimes injected into the buttocks. No peer‑reviewed evidence demonstrates efficacy; the most extensive trial by Duke University showed only insignificant benefits for the 180 children tested.Financial Stakes and Pricing of the TreatmentsUp to $20,000 per infusion in U.S. clinics.$12,500 for a single treatment planned for a Utah family.$300 consultation fee plus up to $15,000 per subsequent infusion charged by Better Stem.$2 million investment announced by Ed Clay’s Cellular Performance Institute for a free trial in Tijuana.Families are urged to return for regular “top‑up” infusions, creating a recurring revenue stream for providers.Regulatory and Public‑Health ImplicationsThe FDA has explicitly cautioned that receiving stem‑cell treatments outside an approved trial is likely illegal and potentially deceptive. Past FDA reports cite complications such as blindness, tumor formation, and infections. Providers also invoke the 2018 Right‑to‑Try Act, although the law applies only to terminal, life‑threatening conditions—not autism.Despite the warnings, Robert F Kennedy Jr has appeared at autism‑health summits, promoted the “no longer fringe” status of these therapies, and appointed summit organizer Tracy Slepcevic to the federal Autism Coordinating Committee.Future Outlook for Oversight and Market GrowthA planned trial involving 120 autistic children will begin in Tijuana, with the possibility of later expansion to U.S. sites under full FDA licensing if early results appear promising. However, the “wild‑west” environment highlighted by the secretary suggests continued regulatory gaps, allowing both reputable and fly‑by‑night clinics to operate.Continued political endorsement combined with high parental desperation is likely to sustain demand, while enforcement actions and clearer guidance from the FDA will be critical to curb unsafe practices.
#Robert F Kennedy Jr
#Autism
#Stem cell therapy
Read More