Validation of the biocompatibility of a cell transplantation device for the treatment of diabetes

Endocrine diseases have a significant public health impact worldwide, leading to long-term disability and impairment of quality of life for affected patients. The most prevalent endocrine disease is diabetes mellitus, affecting more than 537 million people worldwide. About 10% of these patients suffer from type 1 diabetes (T1D), an autoimmune disease that leads to insulin deficiency by destroying the insulin-producing beta cells of the pancreas and requires the regular administration of insulin. Currently, insulin replacement therapy is the first therapeutic option for the treatment of T1D. Although it is the most widely used treatment for these patients, it cannot fully replicate the biological effects of endogenous insulin due to the lack of counter-regulatory hormones such as glucagon. Current treatments can only ameliorate the effects of diabetes by preventing hyper- and hypoglycemic events, but cannot provide a cure. Patients are dependent on regular administration of exogenous insulin for the rest of their lives. Pancreatic islet transplantation is a treatment for severe courses of T1D, and is the only one that restores the interplay of islet hormones, including insulin, glucagon, and somatostatin. Excellent survival of transplanted islets has been reported, and the treatment produces very good regulation of blood glucose. However, this treatment option is very limited due to the lack of suitable donor organs and limited by the permanent immunosuppression required. With recent advances in the differentiation of insulin-producing cells from human induced pluripotent stem cells (hiPSC) new cell sources are now available. Protection of these transplanted cells from the patient’s immune system is an essential step for the success of these technologies to circumvent immunosuppression. Furthermore, the encapsulation itself can protect the patient from yet unknown risks of these cell sources such as dedifferentiation into cancerous tissue.