He has also launched a Texas-based company called Aidan Products that sells nutritional supplements. Riordan is the founder of several other clinics, including one in Costa Rica that was shut down by the government there in 2010 and one in Southlake, Texas, that is still operational. The Stem Cell Institute, on its website and Facebook group, hosts videos and shows pictures from American athletes and celebrities including the actor Mel Gibson to promote its offerings. Riordan says the institute has treated hundreds of children with autism. One Facebook group devoted to the cause has more than 9,500 members, for instance, and several members ask for advice on whether to travel to Panama. Thousands of parents have pinned their hopes on stem cell treatments for autism. The actual treatments were provided free of charge.” Weeks says that the trial, travel, and other expenses totaled more than $20,000. But Riordan tells Spectrum that the $7,200 the institute charged parents was “to defray costs outside of the treatment. Riordan and his colleagues did not mention in the paper that the families had to pay for the infusions. The placebo effect is amplified when parents pay to participate or when the therapy is invasive, because parents are invested in having the treatment work, he says. Parents of autistic children are particularly vulnerable to placebo effects, says Jeremy Veenstra-VanderWeele, professor of psychiatry at Columbia University in New York who was not involved in the trial. However, the parents and the researchers were all aware that the participants had received the treatment. The scores of eight of the children improved on these tests, according to the parents the researchers did not report scores for the other seven, and did not explain why. The team gave parents of the participants two questionnaires-the Autism Treatment Evaluation Checklist and the Childhood Rating Scale-before and after the trial. The treatment did not seem to have any serious side effects, the researchers say. The children received four stem cell infusions over four days every 12 weeks for nine months each dose takes five minutes to administer, Weeks says.Ĭhildren reported several instances of mild fatigue, headache, and fever, and their parents reported fewer instances of obsessive-compulsive behavior and tics. Weeks says Aaron was one of the 15 autistic children aged 6 to 15 who completed the trial 5 children dropped out. The Stem Cell Institute used cultured cells in its trial, a practice that is legal in Panama. However, it is illegal in the US to culture stem cells for treatments without federal approval. The treatments must use stem cells from umbilical cord blood or bone marrow. Food and Drug Administration has approved the use of stem cells for blood disorders, including cancer, but not for autism. “Those running the study financially benefit from it, and stand to benefit if the results turn out a certain way.” Placebo problem “It’s not right to charge patients for unproven stem cell injections, even in the context of a study,” says Paul Knoepfler, professor of cell biology and human anatomy at the University of California, Davis. Other experts question the ethics of making families pay to participate in such trials. There is also no convincing explanation for how the stem cells might treat autism, he says. But he cautions that the findings are about safety only, and neither study tested the treatment against a placebo. “When there’s more than one group reporting similar results, it tends to look more like a validation,” says Arnold Kriegstein, professor of neurology at the University of California, San Francisco. The results echo those of a 2017 study at Duke University that reported that infusions of stem cells taken from stored umbilical cord blood are safe. “The trends observed in this study are indicative of potential therapeutic benefits,” lead researcher Neil Riordan, founder of the Stem Cell Institute, writes in an email sent to Spectrum by a spokesperson. Some experts question the ethics of making families pay to participate in such trials. Still, it hinted at small improvements in motor skills and social behaviors, according to the study. The trial enrolled 20 autistic children, but did not include a control group who didn’t receive stem cells-and so was not designed to assess the treatment’s effectiveness. Findings from the small trial, published in June in Stem Cells Translational Medicine, suggest that this type of stem cell infusion is safe for children with autism.
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