A small step forward for extremely hard-to-control diabetes

WASHINGTON, D.C. (WPVI) -- The 40-year quest to help some diabetics with transplanted insulin-making cells may be getting closer.

New research shows transplanting pancreas cells can help prevent a life-threatening complication for some people with hard-to-control Type One Diabetes.

That's an important step toward getting federal approval.

They're called Islet cells, and they are in the part of the pancreas that produces insulin.

A study funded by the National Institutes of Health at 8 medical centers, including the University of Pennsylvania, looked at transplanting these cells from a donor to people with high-risk Type One Diabetes.

Some of those patients can experience sharp drops in blood sugar levels but often with NO warning signs.

Islet cell transplants are used in some countries, but are only available through clinical trials in the U.S.

Scientists have been trying for decades to figure the best way to harvest those cells from deceased donors, and which patients would get the most benefit from them?

Different hospitals used different methods to cull them and prepare them for patients.

The FDA made clear that there had to be a standard method for islet cell transplants if they were ever to be approved - which is necessary for insurance coverage - so the researchers developed the recipe used in this trial.

The Phase 3 trial shows of the 48 people who received the islet cells, more than 85-percent had good control of their blood sugar level and no severe drops for at least a year.

More than half were also able to stop using insulin.

But the transplants also come with risks, including infections and lowered kidney function as a result of people taking the immune-suppressing drugs needed to prevent rejection of the donor islets.

Although some of the side effects were serious, none led to death or disability.

In the United States, islet transplantation is no approved by the Food and Drug Administration, and is currently available only in clinical trials.

Even with the best care, about 30 percent of people with type 1 diabetes aren't aware of dangerous drops in blood glucose levels.
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