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Steps Towards Testing Autologous Stem Cell-Derived Islet Cells in the Clinical Setting

Albert Hwa, United States

Cell Therapy Operations Director
Joslin Diabetes Center, Harvard Medical School


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.


Dr. Albert Hwa is a graduate of Cornell University, where he earned a degree in Chemical Engineering. Dr. Hwa received his PhD in Biological Engineering at Massachusetts Institute of Technology. He is the Operations Director for Joslin's Center for Cell-Based Therapy for Diabetes (CCTD) and a Lecturer at Harvard Medical School. At CCTD, Dr. Hwa works with investigators at Joslin and other collaborating institutions to identify technologies ripe for translation and establish the research programs to bring them to clinical testing. Stem cell-derived beta cells are the primary target for the center for its central role in correcting insulin insufficiency in diabetes.

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