There are not nearly enough donors to go around. Seven hundred thousand people in the United States have type 1 diabetes (islet cell transplantation can’t treat most cases of type 2 diabetes. >Meanwhile, only 6,000 donor organs were available last year — 2,500 of which were not viable for donation. Moreover, most patients need two transplantations to get off insulin injections.
"Islet cell transplantation is wildly successful in the sense that it’s been done in living people who are off insulin and leading a normal life. But it can only help a few people as opposed to many," said Dr. Robert Goldstein, chief scientific officer of the Juvenile Diabetes Research Foundations. .
If the FDA approves islet cell transplantation, which could take three more years, doctors and hospital administrators will have to find a fair way to decide who will qualify for the procedure first.
"The bad news is that with this protocol, there are only enough donor pancreases in the country to meet the needs of 0.2 to 0.5 percent of those who need them. It’s an ethical issue who gets them," said Dr. Joel Habener, director of the molecular endocrinology laboratory at Massachusetts General Hospital and Harvard Medical School.
Habener has an answer. Unfortunately it’s unattainable, at least for now.
"The solution is to make islets in the lab," he said.
No one has figured out how, but they’ve gotten closer using stem cells — both the controversial embryonic stem cells, and the kind taken from adults.
The political and ethical debate surrounding stem cells has been widely reported. People who believe that life begins at conception oppose embryonic stem cell research because the cells are extracted from human embryos, which are destroyed in the process.
Embryonic stem cells have not yet "differentiated" into mature human cells, and they have the ability to become any of the 200,000 types of cells in the human body: hair, blood, skin, toenail and so on.
Embryonic stem cell opponents cite adult stem cells, taken from adult bone marrow, blood or brains, as an answer to the ethical conundrum. But a study published recently in Science by Stanford researchers raised serious questions about the viability of these cells as therapies.
In July, he and his colleagues reported a study in which an intestinal hormone caused stem cells taken from a pancreas to become the islet cells that secrete insulin, called beta cells, and to proliferate.
"We discovered a totally unexpected population of cells in islets and we can grow and keep them in culture for as long as we want to keep them," he said.
Since Habener’s research has not yet been replicated, it’s not certain that stem cells even exist in the pancreas, let alone whether they can really proliferate new insulin-producing cells.
In the meantime the Juvenile Diabetes Research Foundation (JDRF) — which is free of President Bush’s stem cell research restrictions because it raises money privately — has funded several embryonic stem cell studies around the world.
The studies are in the early stages, but many scientists think they hold the most promise for success because they say embryonic stem cells are the most flexible kind.
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