A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation

Type 1 Diabetes Mellitus Clinical Trial

Official title: A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation

Status Recruiting

Clinical Trial Summary

The Cell Pouch™ is a novel implantable device, that is transplanted with therapeutic cells such as insulin producing islets. This combination product is designed for the treatment of Type 1 Diabetes Mellitus (T1D) with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Upon implantation, the Cell Pouch is designed to form a natural environment, rich in tissue and microvessels for the transplant and function of therapeutic cells. The Cell Pouch is designed as a scaffold made of non-degradable polymers, formed into small cylindrical chambers which, when implanted against the abdominal muscle, becomes incorporated with vascularized tissue to the circumference of removable plugs within as early as two weeks as demonstrated in preclinical studies. After the tissue incorporation, the plugs are removed, leaving fully formed tissue chambers with central void spaces for the transplantation of therapeutic cells including Islets of Langerhans (islets). The Cell Pouch forms a natural environment, rich in microvessels that allows the transplanted islets to engraft. It is believed this engraftment will enable long-term survival and function of transplanted islets. This study aims to demonstrate the safety and tolerability of islet transplantation into the Cell Pouch for the treatment of T1D in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. The study also aims to establish islet release criteria that accurately characterize the islet product and are predictive of clinical transplant outcomes into the Cell Pouch, which will be demonstrated through defined efficacy measures.

Clinical Trial Description

The Sernova Cell Pouch is implanted against the abdominal musculature. A minimum of three weeks after Cell Pouch implantation, immunosuppression is initiated and optimized for another 3 weeks. This allows for vascularization of the Cell Pouch chambers and for the patient to be stabilized on immunosuppression prior to islet transplantation. A mass, >3,000 islet equivalent (IEQ) numbers per kg of patient body weight (IEQ/kg), of highly purified islets will be transplanted in the Cell Pouch. The Cell Pouch will be assessed for safety and tolerability for up to three years following the last transplant to Cell Pouch. Data for the primary and secondary endpoints will be summarized using descriptive statistics (such as counts and percentages). ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT03513939
• Study type: Interventional
• Source: Sernova Corp
• Contact: Piotr Witkowski, MD, PhD
• Phone: 773-702-2447
• Email: pwitkowski@surgery.bsd.uchicago.edu
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 7, 2019
• Completion date: September 2025