3027-LB: CRG-002: A Scalable Allogeneic Islet Cell Product Derived from Human Induced Pluripotent Stem Cells (hiPSCs) with Robust Functional Potency and Favorable Safety Profiles In Vitro and In Vivo

Introduction and Objective: Donor shortage limits islet transplantation for insulin-dependent diabetes. We developed CRG-002, an off-the-shelf islet cell therapy from clinical-grade iPSCs. Methods: CRG-002 was differentiated and characterized by flow cytometry and GSIS. Efficacy was tested in vivo. Glycemic control, HbA1c, and C-peptide were measured. Safety was assessed by tumorigenicity and tissue distribution studies. Results: CRG-002 yielded high-purity β-cells with robust GSIS in vitro. It restored normoglycemia in mice and provided sustained control with normalized HbA1c and increasing C-peptide in rats. Grafts contained β, α, and δ cells without teratoma or ectopic migration. Conclusion: CRG-002 is a safe, scalable “off-the-shelf” product with robust preclinical efficacy.