9 reported3 unconfirmed
A Guardian investigation reports that families of autistic children in the US are spending thousands of dollars on unapproved stem cell infusions, a practice scientists call medically unproven. The article focuses on eight-year-old Landyn Holdren, whose mother Christy Holdren paid $12,500 for a first round of treatment in Florida last October and plans to spend another $15,000 this month. The procedure is not approved by the FDA, and scientists say there is little evidence it works for autism. The article notes that US Health Secretary Robert F Kennedy Jr has become an influential ally for stem cell clinics, though he has made no public moves to relax FDA restrictions. A stem cell biologist at UC Davis School of Medicine, Paul Knoepfler, said he has detected a slump in FDA enforcement activity under Kennedy. The article also reports that Dr Chadwick Prodromos, an orthopaedic surgeon who treated Kennedy personally in Antigua, now offers umbilical cord stem cell infusions to autistic children from clinics in Florida and Texas. A campaigner against pseudoscience, Fiona O’Leary, said she was told by a Prodromos staff member that families no longer need to travel overseas because the procedure is newly available in the US, though Florida’s law only covers stem cell therapy for orthopaedics, wound care or pain management.
What’s reported
Landyn Holdren is an eight-year-old autistic child with high support needs who is nonspeaking and self-harming.
His mother Christy Holdren spent $12,500 on a first round of unapproved stem cell treatment in Florida last October and plans to spend $15,000 on a second round.
The procedure is not approved by the FDA, and scientists say there is little evidence it works for autism.
Paul Knoepfler, a stem cell biologist at UC Davis School of Medicine, said he has detected a slump in FDA enforcement activity under Kennedy.
Arnold Kriegstein, professor of neurology at UCSF, called the treatment “completely bogus.”
Dr Chadwick Prodromos, an orthopaedic surgeon, treated Kennedy personally in Antigua for his voice condition and now offers stem cell infusions to autistic children from clinics in Naples, Florida, and Dallas, Texas.
Prodromos told the Guardian he offers the treatment under Florida’s law using the “pain management” category; the law only covers orthopaedics, wound care or pain management, not autism.
Fiona O’Leary, a campaigner from Ireland with four autistic children, said she was told by a Prodromos staff member that families no longer need to travel overseas.
The clinic quoted O’Leary a cost of $20,000 for the first transfusion of 150 million umbilically derived stem cells.
Open questions
Whether the FDA will change its enforcement policy under Kennedy.
Whether the Florida law’s “pain management” category legally covers autism treatment.
How many children have received these treatments and what the long-term outcomes are.
Key figures
Landyn Holdren, eight-year-old autistic child
Christy Holdren, mother of Landyn Holdren
Robert F Kennedy Jr, US health secretary
Paul Knoepfler, stem cell biologist at UC Davis School of Medicine
Arnold Kriegstein, professor of neurology at UCSF
Dr Chadwick Prodromos, orthopaedic surgeon
Fiona O’Leary, campaigner against pseudoscience
Jeff Cohen, health law expert in Florida
Sources: The Guardian