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**Encapsulated human islet cells** are an investigational allogeneic pancreatic-islet replacement therapy evaluated for **type 1 diabetes mellitus**. The product consists of donor-derived human islets of Langerhans, containing insulin-secreting beta cells and glucagon-secreting alpha cells, enclosed within an alginate-based **Monolayer Cellular Device** and implanted subcutaneously. The semipermeable encapsulation is intended to permit diffusion of oxygen, nutrients, glucose, insulin, and other secreted hormones while limiting direct immune-cell access to the allograft, with the goal of restoring physiologic glucose-responsive endocrine function without systemic immunosuppression. The registered Phase 1 study of this specific device-based product was withdrawn.
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