In the first patient to receive its pancreatic cell implant for type 1 diabetes, Sernova’s insulin-secreting Cell Pouch showed no adverse events related to the therapy, and was able to help maintain blood sugar levels over at least two weeks.
In interim results from the phase 1/2 study, the transplant of purified islets demonstrated the production of insulin as well as stimulated C-peptide, a biomarker of the pancreas’ effectiveness in responding to rising glucose levels after eating.
Additionally, the regenerative Cell Pouch was found to integrate well with the blood and lymph vessels of the patient—who saw a weight loss of about 14 pounds (6.35 kg), or about 12% of total body weight.
“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,” said principal investigator Piotr Witkowski, director of the pancreatic and islet transplant program at the University of Chicago.
Using a continuous glucose monitoring system, the patient saw an 87.5% reduction in hypoglycemic events compared to baseline over a two-week period, according to Sernova. In addition, stimulated blood levels of C-peptide and insulin were observed 90 days after the transplant, in a mixed meal tolerance test.
“These results are an important first step towards a paradigm shift in the treatment of this debilitating disease. Our team is looking forward to reporting longer-term results in enrolled patients as the trial progresses,” Witkowski said. The data were presented at the World Congress of the International Pancreas and Islet Transplantation Association in Lyon, France.
Newly enrolled patients with severe hypoglycemia unawareness—where sharp drops in blood sugar fail to trigger the release of epinephrine and common symptoms—will be implanted with cell pouches and stabilized on immunosuppression following the development of vascular tissue and a dose of purified islets.
After six months of monitoring and an assessment of the transplant’s success, patients may receive a second dose of islet cells and will be followed for another year.