Akademik Veri Yönetim Sistemi
Diabetic Medicine, 2025 (SCI-Expanded, Scopus)
Aims: Severe type 1 diabetes (T1D) poses significant challenges due to absolute insulin deficiency, leading to glycemic instability and severe hypoglycaemic events (SHEs). Despite advancements in insulin therapy, some people experience profound instability and impaired quality of life. This article aims to highlight Lantidra (donislecel), the first FDA-approved allogeneic pancreatic islet cellular therapy, as a novel therapeutic option. The manuscript also discusses Lantidra's safety profile, regulatory pathway, and its therapeutic role within contemporary T1D management frameworks. Methods: Isolation, purification, and transplantation protocols of allogeneic pancreatic islets were derived from the pivotal UIH-001 and UIH-002 clinical trials. Results: Pivotal clinical trials in individuals with brittle T1D and hypoglycaemic unawareness demonstrated that a significant proportion achieved insulin independence, with some lasting over 5 years. This was accompanied by a reduction in SHEs and improved HbA1c. The mechanism relies on islet engraftment in the liver, leading to neovascularization and functional beta-cell (β-cell) contribution to glucose homeostasis. However, the therapy carries substantial risks, including complications from the intraportal infusion and lifelong systemic immunosuppression. Consequently, careful patient selection and meticulous post-transplant management are critical. Conclusion: Lantidra is currently reserved for highly selected adult T1D people with problematic hypoglycaemia and labile glycaemia unresponsive to other optimized therapies, where benefits may outweigh risks. Future research aims to improve graft survival, minimize immunosuppression, and explore alternative cell sources to expand β-cell replacement therapies.