The Food and Drug Administration will allow regenerative medicine tech developer Sernova Corp. to begin a new U.S. clinical trial of its proprietary Cell Pouch System for treatment of type 1 diabetes in individuals with hypoglycemia unawareness.
The Cell Pouch is a scalable, implantable macroencapsulation device for the long-term survival and function of therapeutic cells, which then release proteins and/or hormones as required to treat disease. The device is designed upon implantation to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells.
The primary objective of the Phase I/II prospective single arm study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures.
Following approval by the Institutional Review Board, patients with hypoglycemia unawareness will be enrolled into the study under informed consent. Patients will then be implanted with the Cell Pouch including sentinel devices.
Following vascularized tissue development, a dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for safety and efficacy measures for approximately six months. At that point a decision will be made whether to transplant a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year.
JDRF committed up to $2.45 million to support the Sernova clinical trial.
Sernova is a clinical stage company that develops regenerative medicine technologies for the long-term treatment of diseases, including diabetes and hemophilia.
(Source: Sernova Corp.)
Filed Under: Drug Discovery