Cell Pouch System, an implantable device to supply insulin hormone to control diabetes, has been found effective in animal studies, Sernova Corp has announced.
Cell Pouch system has shown positive results in a long-term study evaluating its safety and efficacy a pre-clinical model of diabetes.
Long-term insulin independence was successfully achieved with significantly fewer islets than the current standard of care, requiring only about 10% of insulin-producing islets normally used, Sernova Corp said.
The Cell Pouch System was implanted in pigs which were then made diabetic through removing the pancreas and chemical induction.
Pig’s own islets isolated from the pancreas were transplanted into the device. Standard measures of efficacy including fasting and non-fasting glucose levels, glucose tolerance tests (IVGTT), and C-peptide were taken up to 72 days post-transplant.
At the end of the study period, the device containing the islets was removed and the animals returned to a diabetic state.
Following transplantation, a substantial number of study animals maintained glucose levels within the normal range, showed glucose tolerance tests (IVGTT) similar to non-diabetic animals and were C-peptide positive, an important confirmation of insulin-producing islet function.
Microscopic fluorescence analysis of the device revealed both microvessels and insulin associated with islets.
Upon removal of the Cell Pouch System containing islets, fasting glucose levels returned to the diabetic range and animals required daily insulin injections to maintain normal glucose levels. The animals return to the diabetic state was further confirmed by IVGTT and C-peptide analysis.
From a safety perspective, no adverse events occurred related to the Cell Pouch throughout the study following implantation of over 40 devices for up to 5 months.
The Cell Pouch System devices were well-incorporated with collagen at all time points and yet were not visible under the skin, an important consideration for patients.
“These new data suggest that the Cell Pouch System represent a possible clinically relevant alternative to injection of islets into the portal vein of the liver and may reduce the side effects of transplantation including the instant blood-mediated reaction (IBMR),” Dr. David White, Chair of Sernova’s Scientific Advisory Board stated.
The indication that Cell Pouch System device achieved glucose control with a reduction in the number of islets normally required is also of profound clinical importance as it may increase the availability of life-changing islet transplantation to many diabetic patients, he added.
Sernova believes that the Cell Pouch System has the potential for a wide range of uses in cell therapy including the treatment of diabetes, haemophilia, and other chronic debilitating diseases.
Sernova is planning to commence to test Cell Pouch System in clinical trials soon.
On March 16, 2010, Sernova reported initial results demonstrating that the Cell Pouch System becomes rapidly vascularised and achieved initial glucose control in subject animals.
As many as 9 million Americans require insulin injections and it is the sixth leading cause of death in the United States, according to the American Diabetes Association.
One out of every eight dollars spent on health care in the United States is spent on treating diabetes and its complications. Worldwide expenditures on insulin alone are estimated to be $15 billion annually and growing.
Sernova Corp. is a Canadian-based health sciences company focused on product development and commercialization of innovative proprietary platform medical technologies in the cell therapy arena such as the Cell Pouch System and Sertolin, a technology which, when combined with cell therapy, may protect therapeutic cells without the need for patients to take anti-rejection drugs.