Next-generation preclinical development andassessment of engraftment efficiency of Sernova’s Cell Pouch System™ in clinical islet transplantation
This fellowship will develop next generation Cell Pouch™ technology, through testing novel animal study (anti-cell death agents, insulin-producing mouse stem cells and islet health (metabolic engraftment efficiency) in parallel to a safety and efficacy (Phase I/II) clinical study of the Cell Pouch™ in Type 1 diabetic in which an in vitro measure of islet health will be correlated to in vivo graft function. The Cell Pouch System™ is a patented non-degradable polymer medical device which unobtrusively fits under the skin, rapidly incorporating with tissue and small blood vessels to form a natural environment for the long-term survival of therapeutic cells including insulin-producing islets to provide a tight feedback system allowing insulin release for glucose control in diabetes. The scalable Cell Pouch™ has undergone successful initial animal studies, initial concept testing and has been manufactured for small and large animal and human clinical evaluation. This fellowship will continue testing new generations of the Cell Pouch™, which will ultimately improve the efficacy of clinical islet transplantation.