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OZTx-410 is an investigational induced pluripotent stem (iPS) cell-derived cell therapy developed by Orizuru Therapeutics for the treatment of severe or brittle type 1 diabetes, particularly in patients experiencing recurrent severe hypoglycemia. The product consists of high-purity, homogeneous pancreatic islet cell aggregates (iPICs) manufactured from iPS cell stocks using a proprietary small-molecule-based purification process. Formulated as a sheet-like product, OZTx-410 is designed for subcutaneous transplantation to facilitate long-term engraftment and the formation of functional islet structures. Its primary mechanism of action is the replacement or supplementation of depleted endogenous insulin-producing cells, thereby restoring glucose-responsive insulin secretion and stabilizing blood glucose levels. The therapy is currently being evaluated in a Phase 1/1b investigator-initiated clinical trial at Kyoto University Hospital.
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