Recent advancement in manufacturing insulin-producing cells from pluripotent stem cells now allows the production of autologous islet cells from induced pluripotent stem cells (iPSCs). The Boston Autologous Islet Replacement Therapy consortium was established to test this approach in patients who were rendered diabetic due to prior pancreatectomies and exhibit no signs of islet autoimmunity. Significant progress has been made in patient enrollment and characterization, production of clinical-grade patient iPSC lines under cGMP conditions, and adaptation of iPSC lines to 3D differentiation culture into islet cells. At the same time, we are also exploring an extra-hepatic islet transplantation approach. This presentation will briefly summarize the considerations for each component of the program, the progress to date, and the remaining challenges before performing the clinical transplantation trial.
