Upcoming Clinical Trials
A First-in-human Trial of Autologous Induced Pluripotent Stem Cell (iPSC)-Derived Islets: Developing a Personalized Diabetes Therapy First in human trial
PI(s): Dr. A.M. James Shapiro
Site(s): University of Alberta
Project Summary: Islet transplant has been successful in treating some patients with T1D; however, it requires life-long anti-rejection (immunosuppression) drugs and is limited by the scarcity of organ donors. Building on 20 years of experience in islet transplant, Dr. Shapiro and his team will take advantage of their expertise in stem cell and islet biology, immunology, and transplantation to address these challenges by developing a stem-cell based therapy to replace or supplement damaged β-cells in people with all types of diabetes, including T1D, T2D, and surgical diabetes after total pancreatectomy. The team aims to manufacture new β-like cells from the patient’s own blood cells, so they will be accepted by the immune system and no/minimal anti-rejection drugs are needed. In this project, the team will conduct a First-in-human trial to implant these cells under the patient’s skin and evaluate their safety and preliminary efficacy. Manufacturing protocols will be optimized to allow development and scale-up of clinical grade products for therapy. Being able to transplant an unlimited supply of self-derived islet cells without immunosuppressants is a novel approach to treat all forms of diabetes and could be the world’s first functional cure.