Abstract
Advances in human pluripotent stem cell (hPSC) differentiation protocols have enabled cellular replacement therapies to progress to clinical trials. In patients with Type 1 diabetes (T1D), an autoimmune disease eliminates the majority of islet β cells in the pancreas causing insulin deficiency and hyperglycemia. The only treatment option for patients with T1D is injection of exogenous insulin. Clinical trials of allogeneic islet transplants in immunosuppressed patients have demonstrated that β cell replacement therapies are capable of C-peptide production and glycemic control. However, broad applicability of this therapy is limited by donor islet scarcity, variable cell quality and the risks and toxicities associated with immunosuppression. This review will discuss the development and clinical translation of a second-generation β cell replacement therapy for diabetes, hPSC-derived β cells. Improvements in hPSC differentiation and large-scale culture coupled with innovative macrodevice biomaterials and designs will expedite clinical entry of hPSC-derived β cells. Stem cell-derived β cell replacement therapy offers a promising treatment strategy for Type 1 diabetes patients.
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