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Half of Edmonton Protocol Patients Insulin-Free
posted 05/29/04
Half of the 36 patients with type 1 diabetes who have received islet cell transplants under the Edmonton Protocol are insulin-free.

An overview of the ongoing multicenter study was presented by lead investigator James Shapiro, MD, from the University of Alberta in Edmonton, at the 2004 annual meeting of the American Transplant Congress, the joint meeting of the American Society of Transplant Surgeons and the American Society of Transplantation.

Dr. Shapiro reported that half of the first 23 patients were insulin-free. Five became independent after one infusion of islet cells, five after two infusions, and two after three infusions. Six patients rejected their transplants, and there were two drop-outs and three who reduced their insulin dose.

Enrollment in this phase I/II study ended in January 2003 and has now reached its goal of 36 patients, Dr. Shapiro told attendees. Nineteen of the 36 patients who have received transplants are insulin-free. Five of those 19 received one infusion, seven received two infusions, and seven received three infusions. Seven of the 36 are insulin-dependent; six patients had primary islet nonfunction, and four patients withdrew from the study.

For those still taking insulin, there has been a decrease from 36 units at baseline to an average 21 units per day now, he said. For patients who are insulin-free, glucose control has been excellent, with fasting glucose and hemoglobin A1c levels within the normal range, said Dr. Shapiro.

There is still no clear indication why the six patients rejected their islets.

Patients in the study have experienced a range of adverse events, including six patients who had procedure-related bleeding (during 76 transplants), two with portal vein thrombosis, but not in the main portal, and one with a biliary leak. There were 23 serious adverse events, including neutropenia, diarrhea, and mouth ulceration, which was the most common event. But there has been no cytomegalovirus or Epstein Barr virus infection, and no opportunistic infections, lymphomas, or death.

"There's still room for guarded optimism," Dr. Barrett stated, "My only concern is it doesn't seem to me that this is ready for prime-time implementation as a therapy yet."

Bernhard Hering, MD, from the University of Minnesota in Minneapolis, reported that 18 of the 20 patients who received islet transplants at his center (using a slightly different protocol) are insulin-free, and that 11 who received a single infusion have remained insulin-free at one year posttransplant.

At the University of Miami, 14 of the 15 patients in a slightly different protocol were initially insulin-free, said Rodolfo Alejandro, MD. Thirteen patients received two infusions, and one patient received just one. But nine of the 14 patients had a deterioration of glucose control that required them to go back on insulin, Dr. Alejandro said. Two of those patients subsequently dropped out.

Five patients were given a third infusion of islet cells, and two are being considered for another transplant. Dr. Alejandro said that it is not clear why glucose control worsened, noting that the patients had negative panel-reactive antibodies. But monitoring had revealed an elevated expression of cytotoxic lymphocyte genes.

Source: Diabetes In Control.com: ATC 2004: Abstracts 1434, 1435, 1438.

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