Researchers seek FDA approval for diabetes cell transplants

MINNEAPOLIS — Dave Thoen feared being alone at night, knowing he could be blindsided at any time by a debilitating, even deadly, seizure.

The Bloomington, Minn., actuary suffered from both diabetes and a condition called “hypoglycemic unawareness,” which blocks the telltale signs of low blood sugar.  Despite frequent blood tests and obsessive attention to diet and exercise, seizures could strike him like a hammer — like the blackout that occurred one night during a business trip to Los Angeles.  When Thoen regained consciousness, he found himself locked outside his room and covered in blood.  His spasms apparently had caused him to bang his head repeatedly into the nightstand.

“I literally had to crawl to the hotel desk,” Thoen recalled.

Today those fears are a memory. Thoen is one of 48 people to receive a set of groundbreaking experimental treatments at the University of Minnesota, which proved that transplants of insulin-producing cells known as “islet cells” can treat — and sometimes cure — Type 1 diabetes, one of the nation’s most serious health scourges.

After more than three decades of research, a consortium of schools that includes the University of Minnesota has completed testing on the transplant technique.  Now, the University is preparing to apply to the U.S. Food and Drug Administration for a license to become a manufacturing facility.  University officials say a “biological drug license” would allow them to commercialize the new treatment.

“That is completely and entirely unheard of,” said Dr. Bernhard J. Hering, who directs the project.

If the FDA approves, Hering said, a doctor will be able to prescribe human islets instead of insulin injections. Somewhere between 60 and 70 percent of patients who receive the cells could expect to remain insulin-free after five years, Hering said.

Even those who must still take some insulin, like Thoen, say the operation is life-changing.

Before the treatment, Thoen said, he felt guilty relying on family and friends to take care of him. After the treatment, he was able to take his two boys to the Boundary Waters Canoe Area Wilderness on a camping trip,.

“The transformation for me has been just absolutely amazing,” he said.

Some 26 million Americans have diabetes, and the number is growing at a pace that the U.S. Centers for Disease Control and Prevention has called “unsustainable.” About 95 percent have Type 2 diabetes, which is often caused by poor diet and insufficient exercise.  About 1.5 million people have Type 1 diabetes, which results when the body’s autoimmune system destroys its own islet cells.  Some 26 million Americans have diabetes, and the number is growing at a pace that the U.S. Centers for Disease Control and Prevention has called “unsustainable.”  About 95 percent have Type 2 diabetes, which is often caused by poor diet and insufficient exercise. It occurs when islet cells in the pancreas fail to produce enough insulin — a hormone that converts food into glucose — or when the cells cease to recognize it.  About 1.5 million people have Type 1 diabetes, which results when the body’s autoimmune system destroys its own islet cells.

REFERENCE:  Dan Browning; Minneapolis Star Tribune; 14 MAY 2013

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