Canadian manufacturer Sernova has reported positive results from an interim analysis of a Phase I/II clinical trial assessing its Cell Pouch transplanted with islet cells in type 1 diabetes patients.
Cell Pouch is an implantable and scalable medical device that forms a natural environment in the body to house therapeutic cells and enable their long-term survival and function.
In the first trial subject, the device transplanted with islet cells met primary safety measures and clinically significant efficacy outcomes, including glucose-stimulated C-peptide and production of insulin.
Results showed no incidences of Cell Pouch-related adverse events. The device was also observed to be well-incorporated with vascularised tissue.
A 6.35kg weight reduction was found, along with stabilising improvements in all glycaemic control measures. Data further revealed a 87.5% decrease in hypoglycemic events from baseline over a monitoring period of two weeks.
In addition, stimulated blood levels of C-peptide and insulin were observed at the 90-day post-transplant point.
Principal study investigator Dr Piotr Witkowski said: “The first of two doses of islets transplanted into the Cell Pouch is showing safety and early indicators of efficacy.
“Importantly, demonstration of glucose-stimulated C-peptide and insulin present in the bloodstream is definitive proof of islet survival and function in the Cell Pouch.”
The non-randomised, unblinded, single arm Phase I/II trial is designed for patients with hypoglycaemia unawareness.
Once vascularised tissue chambers are developed within the implanted Cell Pouches, patients are stabilised on immunosuppression and then purified islets are transplanted into the device.
The primary objective of the trial is safety and tolerability of islet transplantation into the Cell Pouch, followed by efficacy as evaluated using certain defined measures.