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Human pancreatic islets consist of clusters of endocrine cells, including insulin-producing beta cells, isolated from the pancreas of a deceased donor. In the specific clinical protocol developed by Ospedale San Raffaele for new-onset type 1 diabetes mellitus (T1D), a "minimal" dose of approximately 1,500 equivalent islets (EIQ) per kilogram of body weight is transplanted. The islets are infused into the patient's liver via the portal vein. This cell therapy is part of a multi-drug regimen designed to preserve endogenous insulin production; it is combined with induction therapy using anti-thymocyte globulin (ATG) for T-cell depletion, maintenance immunosuppression with rapamycin (sirolimus), and pegfilgrastim (G-CSF) to support islet engraftment and potentially modulate the immune response. The goal of this approach is to halt the autoimmune destruction of beta cells and maintain C-peptide levels in recently diagnosed patients.
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