The DiabeCell trial is being conducted in six type 1 (insulin-dependent) diabetics. Recipients in this first trial are given the lowest clinically effective dose to demonstrate safety and then dosing is repeated for additional clinical benefit.
The patients receive an initial transplant dose equivalent to 5,000 IEQ (islet equivalents/kg) administered by injection into the peritoneal cavity, followed by a second transplant six months later. Follow up monitoring will continue for 12 months.
The primary efficacy endpoint for the trial is reduction in hemoglobin A1C (HbA1C) levels over the 12-month post-transplant period compared with baseline (week-1). Secondary efficacy endpoints include glucose lability, reductions in hypoglycemia and nocturnal hypoglycemia, reductions in the average daily insulin dose of >20%, changes in endogenous insulin secretion, and quality-of-life changes.
DiabeCell is a pig pancreatic islet cell product that secretes insulin in response to the patient’s blood glucose levels. Living Cell said that the therapy has been developed so that when the recipient diabetic is injected, it is not destroyed by the recipient’s immune system. The natural cells are coated in an alginate gel that forms a tiny capsule around the cells and prevents the patient’s immune system from destroying the transplant.
The 12-month phase I/IIa trial is being conducted at the Sklifosovsky Clinical and Research Institute in Moscow. Once the initial phase I/IIa trial is completed to ensure safety, a second 12-month study addressing the level of its effect in diabetics will be conducted.