Sernova (OTCQB:SEOVF) has performed its first Cell Pouch islet cell transplant in a Phase 1/2 study of Type 1 diabetes patients.
Sernova’s Cell Pouch is a micro-encapsulation device that houses, supports, and protects transplanted cells. The Cell Pouch is implanted first to establish a vascularized environment, followed by transplantation of therapeutic cells – insulin-producing islet cells, in this case.
“The current standard of care, involves islet transplants into the portal vein which has significant limitations including the development of an immediate blood-mediated inflammatory reaction, limited supply of donor organs and the challenges in isolating and obtaining a consistent quality of islet preparations,” Dr. Piotr Witkowski, the trial’s principal investigator, said in a statement.
The trial is testing the Cell Pouch in diabetic subjects with hypoglycemia unawareness to assess safety, tolerability and efficacy. Sernova expects to report preliminary safety and efficacy data in the first and second half of 2019, respectively.
