Sernova Corp. announced the enrollment of the first three of seven subjects in its Phase I/II trial of Sernova's Cell PouchTM for Clinical Islet Transplantation in type 1 diabetes. Sernova is expecting to report preliminary safety data from this landmark clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019. About the Study: The FDA allowed protocol is a Phase I/II non-randomized, open label, single arm, company-sponsored trial, where up to seven diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures including reduction in severe hypoglycemic events and HbA1c as well as survival of islets following transplant into the Cell Pouch. Study subjects will receive Sernova's Cell Pouches including a small sentinel device implanted under the skin. Following a defined period to allow for the development of vascularized tissue chambers within the Cell Pouch, subjects will be stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, will be transplanted into the Cell Pouch. The sentinel Cell Pouch will be removed after approximately 90 days to allow for an early assessment of islet survival in the device. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regard to the transplant of a second dose of purified islets. Patients will then be further followed to assess safety and efficacy for up to one year.