Sernova Corp presented positive interim data from a phase 1/2 trial evaluating Sernova’s Cell Pouch transplanted with islet cells in patients with type 1 diabetes. Sernova’s Cell Pouch demonstrated initial safety, as well as key efficacy measures, including glucose-stimulated blood levels of C-peptide, insulin, and additional measures of glucose control in the first study patient with type-1 diabetes and severe hypoglycemia unawareness. The data was presented at the International Pancreas and Islet Transplantation Association (IPITA) World Congress.
The Phase I/II non-randomized, unblinded, single-arm trial is designed to enroll 7 diabetic subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Subjects are implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch. A sentinel pouch is removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures.
Preliminary data from the first patient showed the following:
- The Cell Pouch was well-incorporated with vascularized tissue, which enabled successful transplant of the purified islets
- No incidences of adverse events determined to be related to the Cell Pouch implant.
- A reduction in body weight
- Stabilizing improvements in glycemic control parameters measured by Continuous Glucose Monitoring (CGM), assessed by Medtronic
- 87.5% reduction in hypoglycemic events from baseline collected over a two-week CGM monitoring period
- Presence of stimulated blood levels of C-peptide and insulin at the observed 90-day post-transplant point as indicated in a mixed meal tolerance test
The Company is actively recruiting and enrolling subjects in this trial and is expecting to report further data in the second half of 2019.
The body’s blood sugar levels are controlled by islets in the pancreas which can release insulin in response to elevated sugar levels. Insulin then works to bring the sugar levels back to normal levels as the cells take up and use the sugar to function. In patients with diabetes, blood sugar rises to an abnormally high level because either the insulin producing islets become damaged or lost or because the cells in the body become insensitive to insulin. The current standard of care of patients with insulin dependent diabetes is insulin injections or insulin delivered through insulin pumps. Neither of these approaches produce tight control of glucose levels.
About Sernova’s Cell Pouch
Sernova’s Cell Pouch System™ is a novel implantable and scalable medical device which forms a natural environment in the body for the housing and long-term survival and function of therapeutic cells. These therapeutic cells release necessary proteins or factors missing from the body to treat chronic diseases as an alternative to daily administration of drugs. Replacement of insulin producing islets through cell transplantation can be a feasible long-term treatment option, especially if the donor islets are protected locally from immune system attack.