Sernova Corp. announced positive interim data from its Phase I/II clinical trial, showcasing the long-term survival and function of islet cells within its Cell Pouch Transplant System in a patient with type 1 diabetes (T1D). The data, presented at the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting, highlight the potential of the Cell Pouch as a functional cure for T1D.
The study's lead investigator, Dr. Piotr Witkowski from the University of Chicago Medicine, presented data demonstrating that after more than five years, the Cell Pouch maintained abundant insulin, glucagon, and somatostatin-producing islet cells. The Cell Pouch acts as a pseudo-organ, delivering therapeutic cells to the body.
Long-Term Islet Survival and Function
Histological data from explanted Cell Pouches confirmed the presence of healthy beta, alpha, and delta cells secreting insulin, glucagon, and somatostatin in all chambers. The explanted Cell Pouches, removed after five years due to non-diabetes related health issues requiring the patient to stop immune suppression, showed robust vascularization and no detrimental fibrotic tissue, material degradation, or changes in the pouch architecture.
"This is a major step forward in the development of a contained and retrievable cell therapy for the treatment of T1D," said Dr. Witkowski. "This is the first evidence that I am aware of that demonstrates this level of healthy islet survival and function in an implantable and retrievable system for such a long duration."
Clinical Trial Details
The Phase I/II trial (NCT03513939) is a single-arm study evaluating the safety, tolerability, and efficacy of the Cell Pouch in combination with transplanted human donor islets in T1D patients. The trial includes participants aged 18-65 who experience hypoglycemic unawareness and severe hypoglycemic episodes and are eligible for donor islet transplantation.
The trial is divided into two cohorts: Cohort A, involving six patients who received the first-generation 8-channel Cell Pouch, and Cohort B, evaluating seven patients transplanted with an optimized 10-channel Cell Pouch, which has a 50% greater islet capacity. Patients are implanted with the Cell Pouch subcutaneously, followed by islet transplantation into the prevascularized tissue chambers approximately six weeks later.
Secondary objectives include assessing continuous glucose monitoring, C-peptide production, insulin use, HbA1c levels, and the frequency of severe hypoglycemic episodes.
Sernova's Vision for a Functional Cure
Sernova is also working with Evotec to develop induced pluripotent stem cell (iPSC)-derived islet-like clusters, providing a scalable cell source for treating millions of patients with insulin-dependent diabetes. The company's pipeline includes cell therapies for hypothyroid disease and hemophilia A.
Jonathan Rigby, CEO of Sernova, expressed his determination to advance the program, stating, "We believe this first-in-world data is significant for Sernova and, more specifically, provides tangible hope for T1D patients that we are a significant step further in our mission of providing a functional cure for this terrible disease."
Diabetes Market and Unmet Needs
Diabetes affects 537 million people globally, with projections estimating 643 million by 2030. Nations spend up to 9% of their health budgets on the disease, with approximately 10% of patients being insulin-dependent. The global market for diabetes devices was estimated at US$30.31 billion in 2023 and is projected to grow at a CAGR of 7.45% from 2024 to 2030.
