Insulin Producing Cell Pouch Approaching Clinical Trials in Humans

January 7th, 2011

A Canadian health sciences company focusing on innovative medical technology has successfully tested an organ-like device containing insulin producing islet cells in animals, and is pursuing FDA approval to conduct clinical trials in humans in 2011. There were no adverse side effects associated with the device during the study, during which the diabetic pigs receiving the insulin delivery system achieved long-term blood sugar control.

Sernova Corporation's patented Cell Pouch System is implanted under the skin, where it develops into what the company refers to as "a tissue engineered pancreas" when infused with islet cells. The islet cells deliver insulin to the body, much as the islet cells of the pancreas do in people and animals without insulin dependent diabetes.

Current islet cell transplantation involves removing insulin-producing cells from a donor pancreas and transferring them through a needle directly into the liver of a person with diabetes. The technology is still considered experimental, and is hampered by the body's immune system, which sees the insulin producing cells as foreign invaders and attempts to reject them. The Cell Pouch protects the cells from the immune system, eliminating the need for powerful anti-rejection drugs, which often have serious side effects. The Cell Pouch would be less costly, and requires only about 10% of the insulin producing islets used in the existing islet cell transplant technique.

According to the American Diabetes Association, diabetes is the sixth leading cause of death in the US. The number of American adults diagnosed with diabetes has more than doubled over the past decade, rising from 9 million to 19 million, largely because of soaring obesity rates. While they are more effective, the newer diabetes medications can cost as much as ten times more than the older generic diabetes drugs. Given the option to both save money and avoid daily insulin injections, most diabetics would welcome the option of the new Cell Pouch.

Sernova Corporation says its Cell Pouch System has the potential to treat a wide range of conditions besides insulin dependent diabetes, including Parkinson's disease, spinal cord injury, and hemophilia.