For most of their lives, Rob Allen and Laura Cochran struggled mightily with this truth: They had Type 1 diabetes, a chronic condition in which the pancreas produces little or no insulin.
Daily insulin infusions had been their lot in life. And as they got older, horrible episodes caused by low blood sugar would hit them unawares.
And so when they learned the Emory Transplant Center was conducting a clinical trial to confirm earlier study results on the effectiveness of islet transplants, it was the first bit of hope they’d had.
They didn’t know quite what to expect in the beginning, but after decades of poking and sticking themselves, blacking out in public, a miracle would be nice.
A decade ago, after just two infusions of islets from pancreatic donors, it happened. They got their miracle. Not only had the transplant eliminated their need for insulin injections, it had restored their ability to sense low blood sugar.
“I almost didn’t know how to handle it,” Allen said when he learned he was diabetes free. “I had had the condition for 35 years. It was real different because I didn’t know anything else.”
Allen, 63, of Lilburn, and Cochran, 55, of Columbus, are among hundreds of people across the country suffering from Type 1 diabetes who’ve benefited from islet transplantation freeing them from complete dependence on insulin and the life-threatening consequences that come with the disease.
The procedure, however, still is regarded as experimental by the U.S. Food and Drug Administration. Emory stopped enrolling patients for the trial in 2005 but were in long-term follow-up until about a year ago, doctors said.
They said they have no idea when the FDA, which is still reviewing the data, will make a decision.
Islets are clusters of insulin-making cells in the pancreas that are destroyed in people with Type 1 diabetes. After transplanting islet cells from a donor pancreas, the new islet cells can begin to produce insulin, a hormone needed to allow glucose to enter cells to produce energy.
According to Dr. Christian Larsen, the Emory transplant surgeon who headed up the trial with Dr. Nicole Turgeon, early experiments in islet transplantation were considered failures, but interest was rekindled in 2000, when researchers from the University of Alberta in Edmonton developed a new islet-transplant protocol that increased insulin-independence rates from about 15 percent to about 80 percent.
“It’s pretty miraculous that you can infuse a small number of cells into the pancreas and it completely reverses diabetes when the transplant is successful,” Larsen said.
Turgeon said that the number of islet cells needed — generally between 8,000 and 10,000 per kilogram — for a successful transplant depends upon the patient.
For example, she said, “You could give two patients the same number of islets. One would become diabetes free and the other would not.”
Cochran and Allen were among eight patients who participated in the Emory trial, launched in 2003, and are the only ones who have been diabetes free for 10 years.
“The others have had variable functions and some have had what’s called partial function, which means they are on a much lower dose of insulin and are also free of hypoglycemic unawareness,” Turgeon said. “We have one patient who is insulin independent from another trial who is now five years diabetic free.”
Larsen said the transplant, which takes about 15 minutes, is done through a small incision in the abdomen, where an IV is placed into the vein going to the liver. Then using a slow-drip method, he said, hundreds of thousands of donor islet cells are transferred into the patient.
“Those islets make their way from the liver to the pancreas to restore insulin production,” he said.
Allen and Cochran both received two islet cell transplants from two different organ donors, several months apart. After the first transplant, they still needed small amounts of insulin injections. But after the second transplant, they no longer needed the daily injections.
“We transplanted just two teaspoons of islet cells into these patients 10 years ago, and they no longer need insulin injections,” Larsen said. “It’s a wonderful surprise. We’re excited for these patients. Very excited.”
In all, Turgeon said 19 patients have received islet cell transplants in four different clinical trials at Emory over the past decade.
The transplant, she said, is not recommended for all Type 1 diabetics. Nor is it for the more common Type 2 diabetes, which occurs when the body becomes resistant to insulin or doesn’t make enough insulin.
Like with all organ transplants, recipients, including islet cell recipients, must take anti-rejection medications the rest of their lives.
Both Allen and Cochran said they found out about the trial from newspaper articles and applied to be a part of the Emory effort in 2003.
After months of testing, they were each invited to participate.
Cochran got her transplants in May 2004 and Allen in late December 2003 and January 2004.
“It completely changed my life,” Cochran said. “As a mother of young children, it has been a lifesaver. We lived and breathed diabetes because it doesn’t just affect the patient, it affects the entire family.”
Allen’s wife, Lisa, agreed, saying more than once she came home from her nursing job to find her husband blacked out on the floor. Not anymore. Not in 10 years.
“This January will mark 11 years without one drop of insulin,” Rob Allen said. “I haven’t had another hypoglycemic incident. I haven’t had to do anything except enjoy life. My only hope now is the FDA OKs this procedure so no one else has to suffer.”
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