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Allogenic islet cells (human, U. Chicago) is an allogeneic cell therapy consisting of purified human pancreatic islet cells isolated from deceased organ donors. Developed by the University of Chicago, this biologic product is intended for the treatment of patients with brittle type 1 diabetes mellitus who experience severe hypoglycemic episodes and hypoglycemia unawareness despite optimal insulin therapy. The therapy is a cell-based biologic product administered via intraportal infusion into the patient's liver through a minimally invasive radiological procedure. Once lodged in the liver's blood vessels, the transplanted insulin-producing beta cells function as a bio-artificial organ, producing insulin in response to blood glucose levels to restore glycemic control and eliminate the need for exogenous insulin injections. The University of Chicago has conducted multiple Phase 1/2 clinical trials evaluating the safety and efficacy of this approach and has been working toward a Biologics License Application (BLA) submission to the FDA.
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