Unapproved Stem Cell Treatments for Autism: A Growing, Risky Trend

Clinics in Florida, Texas, and several other US states are now offering unapproved stem cell treatments for autistic children, primarily using umbilical cord stem cells. The procedures cost up to $20,000 per treatment and involve sedating children with ketamine before administering intravenous stem cells. Families are advised to return for regular "top-up" sessions.

The FDA warns that stem cell treatments offered outside approved clinical trials are likely illegal and potentially harmful, citing risks such as blindness, tumor formation, and severe infections.

Political Support and Regulatory Shifts

US Health Secretary Robert F. Kennedy Jr. has expressed support for alternative therapies, including appearing at summits organized by Autism Health—a group that actively advocates for stem cell infusions in autistic children. Kennedy has also reduced funding for autism research by $31 million, fired federal health officials, and attempted to limit childhood vaccinations.

This political backing comes despite clear warnings from federal regulators. The FDA has stated plainly that patients offered these treatments outside approved clinical trials are likely being deceived.

Legal Loopholes and Questionable Practices

Some clinics invoke the federal Right to Try Act to justify their treatments. However, health law expert Jeff Cohen clarifies that this law applies only to terminal illnesses and does not cover non-life-threatening conditions like autism.

The scope of the problem extends beyond human stem cells:

• Some providers use animal stem cells from sheep and rabbits
• Other clinics operate in Mexico, where regulations are looser
• A new experimental trial in Tijuana, Mexico, plans to inject 120 autistic children with umbilical cord stem cells, with ambitions to expand into the US if results appear promising

Mike Chan, a physician using animal stem cells, defended the practice by stating: "Man himself is an animal, the most intelligent animal. There are hundreds of drugs from animals."

What the Science Shows

A major clinical trial at Duke University found no significant benefits for most of the 180 children tested with stem cell treatments for autism.

The bottom line: While families seeking help for their autistic children may be drawn to these expensive, unproven treatments, federal health authorities and clinical research both indicate that the risks—including blindness, tumors, and infections—significantly outweigh any potential benefits.