A “New Life”

Human islet Transplants offer “new life”

For roughly a decade, up to five times a month, Dave Thoen had diabetic seizures while in the middle of a conversation, in the car, and even while sleeping. He never knew when on might strike, and his family and friends had to help him in sometimes life- threatening situation.

For type 1 diabetics like Thoen, the body mistakenly destroys insulin-producing islet cells in the pancreas and cannot properly regulate blood glucose. Like some diabetics, Thoen suffered from hypoglycemia unawareness, a complication in which he did not experience early signs of dangerously low blood sugar, such as sweating, dizziness and extreme hunger – he would just have a seizure or lose consciousness.

Fortunately, Thoen was eligible to participate in the University of Minnesota’s human- to-human islet cell transplantation clinical trial. While islet transplantation remained experimental since the 1970’s recent clinical trial outcomes have made huge gains. Now diabetes physicians, researchers – as well as patients like Thoen – view transplantation as a cure for diabetes.

In 2008 the University of Minnesota was selected as one of three principal sites to conduct phase 3 clinical trials in human islet transplants – the final round of study before the U.S. Food and Drug Administration (FDA) determines whether it can be used as a standard therapy for diabetes. There trials are coming to a conclusion and the future looks bright for islet cell transplants.

Overcoming Challenges
Because the opportunity to make islet transplantation widely available may soon be a reality and holds such great potential researchers are focused on solutions for possible roadblocks.

There is a limited supply of human islets, which come from deceased donors. So, Dr. Bernhard Hering, M.D., SDI’s scientific director, is researching whether islet cells from medical grade-pigs could be used for human transplants. Dr. Hering performed a pivotal pre-clinical trial to test pig islet cell transplants in monkeys. In this study Dr. Hering successfully cured type 1 diabetes in 23 of of 25 monkeys using transplanted pig islet cells from Spring Point Project pigs. This level of success had never need achieved before. However what was discovered was that while successful there are concerns with the immunosuppressive drugs. After much consternation the decision was to slightly change direction. The focus of Dr. Hering has shifted in the direction of tolerance. This is a technique that will allow for minimal us of immunosuppression therapy.

Diabetes is History
For Dave Thoen, despite anyone trial side effects from islet cell transplants, deciding to undergo the procedure was easy. “At the end of the day, ‘ Is it worth the side effects? Wasn’t even a question for us. The number of times I could have killed myself or someone else (for I expected seizures) made any side effects from immunosuppressive drugs a much better option.”

In December 2008, Thoen received an islet transplant that rid him of hypoglycemia unawareness dropping his need for insulin to just one- third of what he once required.

Then in August 2009, Thoen underwent a second islet transplant and within a few weeks he was able to stop taking insulin altogether. “Diabetes is history,” he says, after living with diabetes for 22 years. “My family doesn’t worry about it. Hypoglycemia and insulin aren’t even in our vocabulary.”

Phase three clinical trials are completed and final FDA while on the horizon is not in hand. The recipients of islet transplantation are getting a much better quality of life.

Thoen is among them. “We have quickly adapted to this new life (without diabetes), and it has been a wonderful gift.

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