Canada-based medical device company Sernova has started patient screening and recruitment critical trial for its regenerative medicine trial in the US for diabetic patients with hypoglycemia unawareness.
The company said that its initial clinical evaluation of the prevascularized Cell Pouch showed biocompatibility and safety of the Cell Pouch along with viability and vascularization of its transplanted insulin-producing islets.
The study is a Phase I/II, non-randomized, open label, single-arm, company-sponsored trial, which will be conducted under the leadership of University of Chicago Medicine surgery associate professor and pancreatic and islet transplant program director Piotr Witkowski.
Subjects with hypoglycemia unawareness enrolled in the study will be implanted with the Cell Pouch. Following vascularized tissue development in the Cell Pouch, an initial dose of purified islets under strict release criteria will be transplanted into the Cell Pouch.
Witkowski said: “This first-in-human work helped frame the design of Sernova’s new Phase I/II clinical protocol. Our clinical team at the University of Chicago is excited to initiate this trial of Sernova’s transformative technology.”
Sernova president and CEO Philip Toleikis said: “To support the clinical study’s timely execution under the highest quality standards, Sernova and CTI (Clinical Trial and Consulting), a well-respected clinical research organization with deep experience in the regenerative medicine field, are working closely with Dr. Witkowski’s team.”
Sernova’s Cell Pouch is a new, scalable and implantable prevascularized macroencapsulation device, which has been designed to be a long-term survival and function of therapeutic cells. They release proteins and/ or hormones required for treating a disease.
The device has been designed to eliminate concerns of fibrosis upon implantation and function of therapeutic cells. It is claimed to have shown long- term safety and efficacy in small and large animal models of diabetes and can provide biologically compatible environment for insulin-producing cells in humans.
In May this year, the company secured University of Chicago Institutional Review Board (IRB) approval to begin a new clinical protocol for the US Food and Drug Administration (FDA)-cleared human clinical trial to investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in patients with hypoglycemia unawareness.
The university’s review board is a committee established to review and approve research involving human subjects. Its purpose is to ensure that all human subject research is conducted in accordance with all federal, institutional, and ethical guidelines.