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ATLANTA—Wendy Kenny, a 42-year-old pharmacist from Covington, Georgia, gave herself five injections of insulin on Wednesday, March 19 a routine she has been following since the age of nine, when she was diagnosed with type 1 diabetes. In the early hours of Thursday, March 20, she entered Emory University Hospital and received the first islet transplant ever performed in Georgia. Her transplanted islets began functioning normally, and Wendy has not needed any additional insulin for the first time in 33 years. Friday evening she ate dinner, checked her glucose reading, found it to be normal, and was discharged from the hospital.
"It’s super," said Ms. Kenny. "I feel great today, and my family is still looking at me in disbelief. I’m thankful to be the first patient in Georgia."
Emory University physicians are helping pioneer the new islet transplant procedure with the goal of freeing patients from having to take insulin and of correcting dangerous fluctuations in glucose levels that could lead to severe complications. For example, Ms. Kenny’s blood glucose level often dropped so low that she would pass out before being aware of it.
ype 1 diabetes is a disease that usually occurs early in life and affects more than one million Americans who are unable to manufacture their own insulin because their pancreatic islets do not function. More than 16 million Americans are affected by type 1 and type 2 diabetes.
The islet transplant in Ms. Kenny marks the beginning of an investigational clinical trial at Emory that is modeled after a successful procedure in Alberta, Canada referred to as the "Edmonton Protocol," which began in 2000 and has now been performed in approximately 250 patients in 15 centers worldwide. Islets are harvested from a donor pancreas and injected through a small incision into the liver of the recipient, with the goal of restoring normal insulin production. In Ms. Kenny’s case, the entire procedure lasted less than one hour.
"We have been preparing for two years to be able to do this first transplant," said Christian Larsen, MD, DPhil, the Carlos and Marguerite Mason Chair in Transplantation Biology and director of the Emory Center for Transplantation. "To have the first patient do so well feels really good. We intend to do three or four additional transplants with this protocol, then move as rapidly as possible toward ten more transplants using approaches we have developed here at Emory."
Emory’s program received a boost a year ago with the opening of its new Center for Islet Transplantation with support from the Juvenile Diabetes Research Foundation (JDRF) and the Livingston Foundation, and most recently from the Delta Air Lines Foundation and the Parker family of Atlanta.
The center is addressing an important issue that faces patients undergoing the potentially curative procedure. They must take a lifelong regimen of immunosuppressive drugs in order to prevent rejection of the islets. The drugs have toxic side effects and greatly increase the recipients’ risk of life-threatening infections and cancer. Even though the Edmonton protocol uses a steroid-free combination of drugs that is less toxic than traditional immunosuppressive drugs, at least one of the drugs still has serious toxic side effects, making the treatment strategy advisable only for those patients with advanced cases of diabetes.
Dr. Larsen and his colleague Thomas C. Pearson, MD, MPhil, have been leading the transplant field in developing strategies that may eventually allow true immune tolerance and long-term acceptance of transplanted organs and tissues without the need for harmful immunosuppressive drugs. They plan to use a new class of compounds they developed, called "co-stimulation blockers," in a subsequent clinical trial of islet transplants. The new drugs already have proven successful in pre-clinical trials in non-human primates at Yerkes National Primate Research Center, and have shown very promising results in human clinical trials in protecting kidney transplants from immune system attack.
Although whole human pancreases sometimes are transplanted into patients with advanced diabetes, along with a transplanted liver, the risks and complications are high. Since the early 1970s scientists have been working on techniques to isolate islets for transplant. Islets are clumps of cells that represent about one to two percent of the mass of the human pancreas and are scattered throughout the organ like salt and pepper through a banana. Often several donor pancreases are required to complete the islet transplant procedure for one patient, although within the past five years more efficient purification techniques have been developed using new enzymes to break down the pancreas tissue and make it easier to extract the islets.
Although many patients require two transplants to get enough islet cells, the Emory doctors believe Ms. Kenny will only require one transplant. The biggest changes in her life, she says, will be "having a lot more freedom, not having to worry about low blood sugar, and being able to change my diet."
"Our ultimate goal is to be able to offer islet transplantation as the preferred form of therapy to prevent the devastating complications of type 1 diabetes," Dr. Larsen said.