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Large-Animal Trials of Islet Sheet Begin

January 17, 2012

Today the definitive large-animal study of the Islet Sheet encapsulation device kicked off with the first surgical procedure under the approved protocol. This was a practice pancreatectomy on a canine recipient, followed by islet isolation. The islets will be used to test Islet Sheet fabrication and in further experiments.  The trial is being jointly conducted at the new Cedars-Sinai Diabetes and Obesity Research Institute, directed by Richard N. Bergman, PhD, with Marilyn Ader, PhD, (principal investigator on the Islet Sheet Project) as associate director, and at the islet research and production laboratory led by Jonathan R. T. Lakey, PhD, at the University of California, Irvine. The Islet Sheets are designed and fabricated by Islet Sheet Medical LLC of San Francisco.

Because large mammals are very similar to humans in their metabolism, this eagerly awaited trial is crucial to accurately predicting the effectiveness of this form of islet encapsulation for treating type 1 diabetes in people. The Islet Sheet Project unites leading experts in animal physiology and metabolism, islet science, and encapsulation technology. The full protocol for the trial is scheduled to complete in 80 days, with Day Zero in February, so that early results should be available in the spring of this year.