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Four experts review the latest advances in islet transplantation, including results from a major multicenter, phase 3 registration trial. T

“We are now planning the FDA submission of a Biological License Application for islet transplantation,” said Dr. Ricordi. “If successful, it would bring approval in the U.S. for the first biologically active cell product that would allow for islet transplantation to become a reimbursable procedure in the U.S. like it already is in countries like England, Switzerland, and Australia.”

Dr. Ricordi said results from islet transplantations have improved and are now similar to results from solid organ transplantation. “Results are close to 70 percent success, and some centers are achieving more than 50 percent success with islets at five years,” he said.

Results following pancreas transplantation have also improved. The driving factors are improved patient selection and improvements in immunosuppression. The most common candidates for pancreas transplants are diabetes patients with uremia. And about two-thirds of pancreas transplant patients also receive a kidney, noted Dixon B. Kaufman, MD, PhD, Chief of Transplantation at the University of Wisconsin School of Medicine and Public Health.

“For patients who have renal failure as a result of diabetes and are being considered for kidney transplantation, it makes sense to implant both organs from the same deceased donor during the same procedure,” Dr. Kaufman said.

These dual transplants offer the greatest benefit to younger patients, but the impact on outcomes can be dramatic.

“Pancreas transplantation is appropriate in select individuals with either type 1 or type 2 diabetes who have significant problems maintaining reasonable A1C using conventional exogenous insulin with or without frequent hypoglycemic events,” Dr. Kaufman said. “Other candidates include individuals who are very labile in their glucose regulation.”

The session’s final speaker, Lorenzo Piemonti, MD, Deputy Director of the San Raffaele Scientific Institute in Milan, Italy, will explore the future of beta cell replacement. He noted that engraftment is a major problem in islet transplantation.

“When you put islets in the liver, they do not like their new home. We lose between 40 and 50 percent of islets the first day, and another half during the first week,” he explained. “You spend a lot of time and money and effort to isolate isles, then you destroy 70 percent of them in the first week because you put them in an environment that is not the natural one.”

The liver is not the ideal environment for islet transplantation, but so far it’s the only site with reliable results using non-autologous islets. Dr. Piemonti has had success implanting autologous islets into bone marrow, with all of the transplants still functioning after five years. Implanting donor islets was less successful.

“One group is trying to put islets in the subcutaneous space, another in the omentum, another in the peritoneum, and another directly into muscle. The liver does not work well for islet transplantation, but there is no evidence in humans that other sites work better.”

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