November 30, 2021

A Controversial Autism Treatment Is About To Become a Very Big Business

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An anonymous reader quotes a report from Motherboard: At Duke University’s Marcus Center for Cellular Cures, parents can enroll their children into a number of clinical trials that aim to study the effects of cells derived from umbilical cord blood on treating the effects of autism and brain injuries; adults can also participate in a trial testing whether cord blood can help them recover from ischemic strokes. And when parents can’t get their children into any of these clinical trials, particularly for autism, they often opt for what’s called the Expanded Access Program (EAP), in which they pay between $10,000 and $15,000 to get their kids a single infusion. All of the trials use products derived from human umbilical cord blood, which is a source of stem cells as well as other types of cells. The autism trials are using a type of immune cells called monocytes, according to Dr. Joanne Kurtzberg, a well-respected Duke professor who’s conducting clinical trials into whether cord blood can help with autism, and who has been researching stem cells since the early ’90s. (On ClinicalTrials.gov, however, these trials are listed as using mesenchymal stromal cells, which are a completely different type of cord blood cell.)

Now, a for-profit company called Cryo-Cell International with ties to Duke researchers has indicated that it plans to open clinics promoting these treatments, under a licensing agreement with the renowned North Carolina university. In their investor presentation, Cryo-Cell said they plan to become “an autonomous, vertically integrated cellular therapy company that will treat patients.” Duke and Cryo-Cell’s rush to monetize a procedure before it’s shown to have solid benefits has created concern, though, across the community of scientists, clinicians, and medical ethicists who study autism treatments. The hope is that these cord blood infusions can improve some autism symptoms, like socialization and language, or decrease the inflammation that some parents and clinicians think might exacerbate autism symptoms. Early study results, however, haven’t been very promising.

A large randomized clinical trial, the results of which were released in May 2020, showed that a single infusion of cord blood was not, in the words of the researchers, “associated with improved socialization skills or reduced autism symptoms.” This is why Duke’s latest move comes as such a surprise: The university and Cryo-Cell have told investors that they’re planning to open a series of “infusion centers.” At these clinics, Cryo-Cell will use Duke’s technology and methods to offer cord blood treatments for $15,000 per infusion. In an exuberant presentation for investors (PDF), Cryo-Cell said it estimates an annual revenue of $24 million per clinic; it hasn’t disclosed how many clinics it plans to open. At least one will reportedly open in Durham, North Carolina. The move follows a June 2020 announcement that Cryo-Cell had entered into an exclusive patent-option agreement with Duke, allowing it to manufacture and sell products based on patents from Dr. Joanne Kurtzberg.

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