Boosted by celebrity endorsements and a controversial research program, clinics are peddling stem cell autism treatments questioned by experts
On November 3, 2004, a researcher kept a package holding vials of human embryonic stem cell cultures from the freezer in La Jolla, California, in Burnham Institute.
Picture of Sandy Huffaker/Getty
Unlicensed hospitals from Central America to Ukraine provide stem cell therapy as autism treatment.
Stem cells mainly used for the prevention of blood disease.
Their autism efficacy is not shown and the FDA has not approved its use.
A famous clinic for such care is the Stem Cell Institute of Panama, whose founder has prominent sponsorship.
Experts told Business Insider that a curriculum of study on stem cells and autism at Duke University legitimizes the clinic.
Parents in unlicensed facilities pursuing care for autistic children offer Duke's work for justification, but he provided little evidence of the work on the treatment.
There was also a critic who pointed out connections between the Stem Cell Institute and a significant donor to the Duke research programme.
Duke firmly rejected contacts with the Panama Clinic, and in a statement to the Business Insider defended his study.
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The Panama Stem Cell Institute website includes glowing testimonials from former patients and louanges from the stars of Hollywood.
Parents explain in one article how the symptoms of their autistic daughters have faded after $15,000 therapy.
She could freshly play with other children and flourished at kindergarten, they added.
"We couldn't be happier as parents we are so proud of her and so thankful to the stem cell institute in Panama for making this possible," they write.
The Institute has good followers.
The site has the Spotify podcast of Joe Rogan, in which producer Neil Riordan and his friend, Hollywood actor Mel Gibson, are interviewed.
Riordan pictures of celebrities such as Instagram star Dan Bilzerian, motivational speaker Tony Robbins, Home Depot billionaire Bernie Marcus, and the actor Josh Brolin are on its Facebook profile.
Panama Clinic is the best known clinic of centuries selling stem cells as a panacea for many diseases, mostly for big costs, from Latin America to Ukraine.
In a study published in The Bone and Joint Journal, several abuse loose local restrictions on the use of stem cells, enabling them to be used for conditions where efficacy is poor.
In recent years, hundreds of poorly supervised clinics have also appeared in the US, according to the Stat News medical website.
Experts are deeply worried about the rise of these clinics, in particular their arguments that autism can be treated.
They argue that the successful treatment of autism by stem cells is unproven and note that it is not approved for this reason by the Food and Drug Administration (FDA).
Some claim that the method can also be disturbing for autistic children.
Amongst them is Richard Mills, Professor of Psychology at the Bath University of Great Britain and Head of the AT-Autism charity.
"Research in stem cells and autism is incredibly weak," he said to Business Insider. "And this is not an approach that we could recommend for autism based on existing evidence, which is why most of us agree there is not enough evidence."
Alycia Halladaay, chief research officer for the Autism Science Foundation, dubbed stem-cell-based autism therapies "unproven," in a Scientific American article last year and attacked media outlets hyping care.
Activists told Business Insider that disinformation in social media distributed across large Facebook communities drives the appeal of stem therapy, particularly though no data has seen that it works.
A legitimate research by scientists from Duke University, North Carolina encourages the trust in stem cells as a potential cure for autism along with rumor, disinformation and conjecture.
While the Duke research and the clinics are two different projects, critics say that there has been a symbiosis of some kind between them.
They say parents quote Duke's study to justify finding care for their children in the clinic in Riordan though Riordan claims to have played a part in giving Duke a significant charitable subsidy.
Duke vigorously rejected any reports of connections in a statement to Industry Insider and urged parents to verify whether stamming cell therapy clinics were licenses.
What are the stem cells, what are they?
Stem cells are present in everything and are able to make up new and specialized cell forms such as blood, bone and brain cells.
They play a significant role in the reconstruction of damaged cells, where focus has focused on their medicinal application.
Stem cells are also taken from blood in extreme umbilical cords after babies are born.
During tests, scientists in labs have developed stem cells and then tested their ability to treat or counteract wounded patients.
In the United States, stem cell therapies must be proven to be successful for certain blood disorders such as leukemia and have been approved by the FDA.
Scientists examine whether a number of other disorders may be handled.
But the FDA cautioned last year against the use of stem cells for diseases where their use is not confirmed.
It said that "some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful."
The Washington Post reported that the use of unlicensed stem cells hospitalized 17 people in the US from 2018 to 2019.
Critics say that a 'symbiosis' has formed between Duke and the unlicensed clinic is following stem cells as autism therapy.
Duke, led by Professor Joane Kurtzberg, is the first clinical trial in the world about whether stem cells can cure autism.
To date, there have been no big breakthroughs for doctors, with Phase 2 clinical tests this year showing no substantial change relative to placebo in stem cell patients.
The team concluded in a July report in the Journal of Pediatrics "not associated with improved socialization skills or reduced autism symptoms."
Students walk under arch at Duke University in Durham, North Carolina on Tuesday 11 April 2006.
Sara D. Davis/Getty Pictures
They concluded that "more research is warranted to determine" whether the therapy is successful.
Other reports, such as one by scientists at Sacramento University in 2018, have also shown no advantages for autistic people with stem cells.
Participation in the Duke trial is not free of charge.
Insider was confirmed by a University spokeswoman that the extended access service costs $15,000.
Instead, many parents cannot sign up for one of the few places to search for non-licensed clinics, analysts and campaigners have told Business Insider.
While the FDA requires organizations to ask for reimbursement of trial attendance, these can only cover operating costs.
Duke said his premium reflects the "actual cost of the clinical care related to delivering the therapy," according to the FDA regulations.
Paul Knoepfler, a University of California, Davis biologist, has blogged on the bogus medicinal use of stem cells and the Duke Initiative.
"A lot of families tie the Duke program and the Panama clinic together and kind of think of them as not as the same thing but as a continuum," he said.
He described the Duke's relationship with Panama's Stem Cell Institute as a 'symbiosis.'
Knoepfler identified a "mutually beneficial connection where they are both promoting almost exactly the same idea of blood for autism."
Professor Kurtzberg defended her thesis in a statement to Business Insider, stressed that her program is not related to the clinic and said there were solid evidence for continuity.
"Our previous Phase 2 double blind randomized clinical trial evaluating cell therapy found that children with autism who don't also have intellectual disability showed improvements in their communication skills, attention, and brain activity based on EEG," she wrote.
EEG is short for brain scan style electroencephalography.
"We have scientific indications that autism causes neuroinflammation, and we have evidence in preclinical experiments that certain cells within the cord of the blood are dampening inflammation in the brain.
Kurtzberg explained that parents who are participating with the extended access scheme 'are charged the real cost of the health treatment related to therapy delivery, in this situation the cord blood unit is not charged.
Possible ties to Bernie Marcus Home Depot billionaire
The shared interest should go beyond parallel academic institutions, critics like Knoepfler claim.
To pursue his stem cell research, Duke was given an award by Home Depot co-founder Bernie Marcus, the Marcus Foundation.
It has contributed millions to institutions studying autism therapies.
Spectrum News estimated that it could amount to up to 40 million dollars, but no specific number will be given to either the Duke or the Marcus Foundation.
Riordan appears to know Bernie Marcus and Kurtzberg in a statement written in response to another post about his clinic.
He said that he investigated Duke's proposal for sponsorship by the Marcus Foundation and attended the board meeting that accepted the application.
Neither Riordan nor the Marcus Foundation would respond to comments about whether this was valid.
If this is real, Knoepfler said, it would generate significant conflicts of interest.
He proposed that if so, Duke's researchers would fail to criticize the institute because they thought it would prevail