
Insulin-producing islet cells from pigs offer hope of a new treatment, if not potential cure, for type 1 and possibly any type of diabetes.
MicroIslet Inc. of San Diego is seeking permission from the U.S. Food and Drug Administration to conduct clinical trials of its procedure for transplanting porcine islet cells into humans. The company already has had success in transplanting these cells into primates and other animals.
MicroIslet coats the pig islet cells with alginate -- a material made from seaweed -- to protect them from immune-system rejection, while allowing the cells to receive nutrients and excrete insulin into the blood stream. Rejection of foreign islet cells has been a key problem in human islet-cell transplants.
MicroIslet has developed a special herd of quarantined pigs to produce high-quality islet cells, which are identical to human islet cells save for one amino acid, said Dr. Jonathan Lakey, MicroIslet president and chief scientific officer. Availability and quality of human islet cells taken from cadavers always has been problematic. But porcine islet cells could be readily produced to treat any number of people with the disease, if tests prove effective, Dr. Lakey said.
Linda Siminerio, executive director of the University of Pittsburgh Diabetes Institute, said the MicroIslet announcement is "a hopeful message" from "a very trusted team" of researchers.
"This is very exciting and opens up a whole new area of protecting islet cells," she said. "If there's any team that can pull this off, it's Jonathan Lakey's."
The first set of clinical trials would involve people with diabetes who have undergone kidney transplants and are on immunosuppressant drugs. Dr. Lakey said that group was chosen because strict control of blood-glucose levels is necessary to keep transplanted kidneys healthy.
If early trials succeed, MicroIslet eventually hopes to expand trials to include anyone with type 1 and even type 2 diabetes.
"The company is taking a stand and the time is right to evaluate this technology in patients," Dr. Lakey said. "This is a therapy that a lot of people with diabetes can benefit from."
In type 1, an autoimmune response destroys the insulin-producing islet cells in the pancreas. Insulin allows glucose in the blood to enter cells and be used as energy. Without functioning islet cells, blood glucose levels rise to dangerous levels.
In type 2, a person becomes insensitive to one's own insulin, causing blood sugar levels to rise.
In both types, high blood-glucose levels lead to heart disease, kidney failure, blindness, limb amputations and other health problems. Treatment typically requires medications or insulin injections along with dietary changes and exercise.
About 30 million people in the United States and Canada have diabetes, Dr. Lakey said, so the company's market would be huge. The American Diabetes Association said annual treatment costs of the disease are $132 billion in the United States.
Transplantation of protected porcine islet cells into an abdominal cavity could be a simple out-patient procedure, Dr. Lakey said.
"We are hoping to be in clinical trials in the late third quarter or early fourth quarter of 2008," he said.