Pay to Participate Autism Stem Cell Article retracted | Spectrum

Price tag: Parents of autistic children have been accused of participating in clinical trials that attempt to use stem cells to treat the disease.

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A widely criticized 2019 article describing a study that used stem cells to treat children with autism was withdrawn after the authors failed to reveal that participants paid thousands of dollars to participate.

The withdrawal takes place two years after Spectrum reported that a family member of one of the participants said she paid over $ 7,000 to have her autistic child participate.

The study was withdrawn earlier this week – despite the authors’ objections – after “newly acquired information” again suggested “that participants were charged to participate and that such fee was not disclosed to the journal, which violates the journal’s guidelines on disclosure of funding sources for clinical trials, ”according to the withdrawal notice.

The article, titled “Mesenchymal Stem Cells from the Allogeneic Human Umbilical Cord for the Treatment of Autism Spectrum Disorders in Children: Safety Profile and Effect on Cytokine Levels”, was published in Stem cells Translational medicine and enrolled 20 autistic children aged 6 to 16. It did not include children who had not received the stem cells and therefore was not designed to assess the effectiveness of treatment, according to a blog post Paul Knoepfler, professor of cell biology and human anatomy at the ‘University of California, Davis, published 2019..

Each child received four infusions of stem cells over a 9-month period, according to the study.

The authors of the trial concluded that the stem cells were “safe and well tolerated by the children who participated” in the trial, and that “the treatment-related adverse events were mild or moderate and of short duration. “, According to the study. They also reported minor improvements in motor skills and social behaviors. Of the 20 children who signed up for the trial, 5 dropped out.

Financial disclosures aside, the trial was “significantly disappointing in terms of the conclusions about the effectiveness of cord blood products or stem cell products for autism,” said Professor Leigh Turner. of Bioethics at the University of California, Irvine. Spectrum earlier this year.

“It’s not really a significant contribution to scientific knowledge,” said Turner, who co-wrote a critical letter on the study earlier this year with Jeremy Snyder, professor of public health ethics at the University. Simon Fraser in Burnaby, Canada. “It’s more what is sometimes described as a guarantee of scientific legitimacy to help strengthen the marketing credentials of this company. “

Financial matters:

The essay, which has been cited 23 times, according to the Clarivate Analytics Web of Science, was led by Neil Riordan, a self-proclaimed “Serial entrepreneur‘and the founder, president and scientific director of the for-profit Stem Cell Institute (SCI) in Panama City, Panama, where the trial was conducted. The SCI was established in 2007, according to the website of the Riordan Medical Institute, of which Riordan is the founder and chief scientist.

Spectrum covered the small trial shortly after the article was published in 2019, reporting that one of the families who participated in the trial was charged $ 7,200 for all four visits. Riordan said in a blog post that the story contained “several omissions and errors” and that the thousands of dollars each family paid to participate in the trial went to services provided by outside facilities. He also claimed that the experimental treatment was provided free of charge.

However, in May of this year, in an article by Stem cells Translational medicine, Turner and Snyder claimed that Riordan’s study was “pay to participate” and that the study had “financial conflicts of interest that were not disclosed.”

Riordan and Jorge Paz Rodríguez, co-author of the initial trial, responded to this article, stating that their trial “was not a paid study to participate. In fact, we went to great lengths to ensure that the treatments were fully funded by the sponsor. “

Riordan and Rodríguez awarded the prize of $ 7,200 to “personal expenses that the subject may incur for transportation, accommodation, and meals, none of which is a cost of the treatment, but expenses incurred by the subjects in the process. most of the tests ”.

New evidence:

In August, the journal’s editors closed the case, writing that, “based on the evidence provided, the editors consider this explanation” – the one proposed by Riordan and Rodríguez – “to have no material impact” on their study.

Turner and Snyder then sent the Stem cells Translational medicine Editors “Lots of material (blog posts, Facebook pages, articles, crowdfunding campaigns, list of studies on clinicaltrials.gov, archived SCI web pages, 2019 Spectrum piece by Hannah Furfaro, etc.) documenting that parents of children in the SCI study were charged as a condition of their children’s participation in the study, ”Turner wrote in an email to Spectrum.

“The [Stem Cells Translational Medicine] the editors then contacted the parents – we provided contact details for two of them – and carried out their own investigation in conjunction with the publisher, ”he said.

“It wasn’t just the parents [of] the kids in the study have been charged, although that’s important, ”Turner said in his email. The Riordan SCI also accused the parents of children [who] were not in the study – although SCI did not have convincing evidence of effectiveness. And it has been going on for over a decade now.

The study was withdrawn on November 30. Anthony Atala, the newspaper’s editor, did not immediately respond to requests for comment.

Riordan “strongly” disagreed with the retraction, according to an email from Jay Lenner, Jr., vice president of international operations at SCI, who said Riordan was traveling overseas and that it would be difficult to contact him directly. The company is sticking to its “scientific methodology and clinical trial results,” Riordan said in a statement from Lenner.

“As previously reported in the journal, trial participants did not pay for any collection, processing, storage or preparation of stem cells in the laboratory, or for the clinical application of the cells,” the statement continued. “Years after publication, the editors unfortunately chose to treat these previously disclosed external costs as undisclosed payments to participate, despite our many clarifications to the contrary. “

Other trials evaluating the use of stem cell therapies to treat autism are also underway in the United States, including at Duke University in Durham, North Carolina. Turner said in an email that “patients (or parents of children) have been instructed to participate in trials other than the study conducted by the Stem Cell Institute.” He wrote about some of these ‘pay to play’ trials in a 2017 article in the journal Regenerative medicine.

According to Turner and Snyder’s 2021 article, no stem cell therapy for autism has been found to be both safe and effective in a randomized, controlled clinical trial.

With reporting by Peter Hess.

Cite this article: http://doi.org/10.53053/LAQL3310



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