For years, islet cell transplants — in which insulin-producing pancreatic cells from a donor are implanted in a person with diabetes — have been viewed as a promising long-term treatment for type 1 diabetes that could someday form the basis of a cure. In experiments to date, many people who received this treatment have been able to substantially reduce their insulin requirements — sometimes to zero — and achieve better blood glucose control for months or even years.
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But islet cell transplants aren’t a widely available treatment for several reasons. One is that the most established versions of the procedure require taking drugs to stop the body’s immune system from attacking the transplanted cells, which carry risks such as a higher susceptibility to infections. And donor islet cells are limited in supply.
Still, this procedure is available in many countries to people with type 1 diabetes that has proven difficult to control with conventional treatments, with doctors and medical societies deciding that the benefits outweigh the risks. But not in the United States, where islet transplants are still viewed as experimental.
This should change, according to a new editorial published in STAT. Two doctors, one a professor of surgery and one the medical director of a company involved in drug development, write that the 1.25 million people in the United States with type 1 diabetes should have access to this procedure if they experience large, fast swings between high and low blood glucose levels on a regular basis.
The authors point out that the risks of severe hypoglycemia (low blood glucose) — including seizures, coma, heart attack, or even sudden death — are substantial enough to outweigh the risks associated with islet cell transplants.
They write that islet cell transplants have a track record of effectiveness in studies, with one clinical trial showing that they worked in 80% to 90% of people receiving them across eight locations in North America — virtually eliminating the risk of severe hypoglycemia both one and two years after the transplant.
Islet cell transplants in the United States are treated differently from those in Europe, Canada and Australia largely because of how the Food and Drug Administration (FDA) regulates them, the authors point out. The European Medicines Agency (EMA) treats them like a normal organ transplant, with a waiting list for patients who need them, even though the cells require extraction and processing from a donor pancreas. The FDA views this extra processing as a manipulation that requires potential providers to file an investigational new drug application — a difficult process that also means patients’ insurance doesn’t cover the procedure, due to its classification as experimental.
The authors urge the FDA to change its guidelines for islet cell transplants, treating them like normal organ transplants — as the EMA already does — so that more people with type 1 diabetes can benefit from the procedure.
Want to learn more about type 1 diabetes? Read “Type 1 Diabetes Questions and Answers,” “Living With Type 1 Diabetes: Four Tips to Get You Started,” “Six Type 1 Diabetes Symptoms You Need to Know” and see our type 1 diabetes videos.
A freelance health writer and editor based in Wisconsin, Phillips has a degree in government from Harvard University. He writes on a variety of topics, but is especially interested in the intersection of health and public policy.
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