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Trying to Eradicate Insulin Clinical Trial Under way to See if Cell Transplants



By Maria A. Flores

At the meeting of the National Association for the Advancement of Colored People today, President Clinton announced the beginning of a major multi-nation effort to test if a new pancreatic cell transplant method will help diabetics live without insulin.
  Clinton chose to publicize the trial at the NAACP meeting to bring attention to the fact that African-Americans are almost two times as likely as whites to have diabetes and because the federal government is helping to support the trial.
  Follows Previous Study
  The National Institutes of Health and the Juvenile Diabetes Research Foundation will be releasing $5 million to help support the testing of the new experimental method at 10 centers worldwide. Doctors expect to begin what is to be called the Edmonton Protocol trial in the fall, with centers located in Edmonton (Canada), Miami, Minneapolis, Boston, St. Louis, Seattle and Bethesda. European sites are also planned in Geneva, Switzerland; Giessen, Germany; and Milan, Italy.
  The massive undertaking represents a follow-up to the June 6 publication in the New England Journal of Medicine of a study of eight patients with severe diabetes who no longer needed insulin injections and remained diabetes-free for as long as 15 months ?and counting ?after pancreatic islet cell transplants. Islet cells are the insulin-producing cells in the pancreas.
  The research was carried out by Dr. James Shapiro, director of the islet transplant program at the University of Alberta, in Edmonton.

Not A Cure
  The study represented the first time diabetics had been kept off insulin for more than a year, although doctors have been experimenting with islet cell transplantation for years. Researchers attribute part of the Edmonton success to a different regimen of immunosuppressive drugs after surgery. Instead of using cyclosporine and steroids, which researchers believe damage islet cells, the doctors used three other anti-rejection drugs.
  While this new research offers hope, doctors caution it is not a cure that’s ready for all diabetics, because all the patients will have to take a regimen of immunosuppressants for the rest of their lives.
  “We’re talking about a small population of people who have a lot of trouble with their diabetes, such that it is a reasonable tradeoff for them to take immunosuppression,?says Dr. Gordon Weir, director of the islet transplant program at Joslin Diabetes Center at Harvard. “I think that we will find better regimens to use that will be even less toxic.?/p>

Eliminating Insulin
  Overseen by the Immune Tolerance Network, a coalition of government and nonprofit groups, the trial will try to repeat the successful results seen by the researchers in Edmonton, and to confirm that this procedure can produce long-term islet survival that eliminates the need for insulin.
  Under the protocol, approximately 40 patients will receive islet transplants in the next 18 months. Only Type I diabetes patients, between the ages of 18 and 65, who are unable to control their blood sugar with even the most rigid insulin schedule are eligible to participate.
  Type I diabetes, also known as juvenile diabetes, affects about 1 million Americans, or 10 percent of diabetics. Twenty-five percent are minorities. They are believed to have an auto-immune disease in which the immune system attacks the islet cells, making them dependent on insulin. Without insulin, diabetics cannot metabolize sugar in their diet.
  Type II diabetes is a metabolic disorder affecting the other 90 percent of diabetics, hitting individuals later in life as a metabolic disorder. Often Type II can be controlled by weight loss, improved nutrition and exercise, although many need insulin and other oral medications to control their diabetes.

African-Americans at Risk
  African-Americans are almost two times as likely to have diabetes as non-Hispanic whites. According to a survey from 1988 through 1994 of people between the ages of 40 and 74 years of age, 11.2 percent of whites have diabetes compared to 18.2 percent of blacks. The disease is often underdiagnosed in African-Americans.
  Diabetics who are interested in participating in the trial can go to the network’s Web site, at www.immunetolerance.org and fill out an application. It will require a signature from their personal physician.
  The Immune Tolerance Network has yet to receive approval from the Food and Drug Administration to go ahead with the trial, but its director, Dr. Jeff Bluestone does not think it will be a problem. He expects to have the first patients enrolled in the trial by the end of the summer.

Lack of Donor Organs
  Should this trial be successful, the biggest limitation to implementing it more widely is the lack of donor organs. Islet cell transplant requires whole human pancreases from brain-dead donors. Only about 4,000 organs become available each year, an amount that sharply limits the number of diabetics that could benefit from the new procedure. This multi-center effort will be overseen by the network, a research program funded jointly by the National Institute of Allergy and Infectious Disease, the National Institutes of Diabetes and Digestive and Kidney Disease and the Juvenile Diabetes Foundation. The researchers will perform the trial under the direction of Edmonton’s Shapiro.

(From ABCNEWS)

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