Sernova Cell Pouch with allogeneic islets of Langerhans

**Sernova Cell Pouch with allogeneic islets of Langerhans** is an investigational biohybrid regenerative-medicine combination product developed by Sernova for type 1 diabetes mellitus in people with hypoglycemia unawareness and recurrent severe hypoglycemic episodes. The therapy consists of highly purified human donor pancreatic islets transplanted into a surgically implanted, prevascularized, retrievable Cell Pouch scaffold positioned against the abdominal musculature. The vascularized tissue chambers support islet engraftment and long-term glucose-responsive endocrine function, with the aim of restoring endogenous insulin secretion, improving glycemic control, reducing severe hypoglycemia, and potentially enabling insulin independence. The donor-islet Cell Pouch program is being evaluated in the Phase 1/2 NCT03513939 study. ([clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03513939))

Other names

Cell Pouch Bio-hybrid OrganSernova Cell PouchSernova Cell Pouch with clinical islet transplantation