NIH Testing Pancreas Cell Transplants

On July 13 the National Institutes of Health announced that ten research centers will soon begin testing a promising technique for transplanting insulin-producing pancreas cells, a process they hope will allow people with type 1 diabetes to stop taking insulin injections. This "Edmonton Protocol" is among the first study to be carried out in the $144 million Immune Tolerance Network (ITN), and international consortium of clinical researchers dedicated to developing immune "tolerance". If successful, these approaches will selectively modulate the immune system responses while keeping protective ones intact. The ITN is a seven year effort headed by the National Institute of Allergy and Infectious Diseases (NIAID) and co-funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Juvenile Diabetes Foundation International (JDFI). Both NIAID and NIDDK are components of the U.S. government's National Institutes of Health (NIH).

Starting this fall, the ITN will spend $5 million to expand studies of the Edmonton Protocol in centers located in Edmonton (Canada), Miami, Minneapolis, Boston, St. Louis, Seattle, and Bethesda, MD. European sites are planned in Geneva, Gissen, and Milan. Approximately 40 patients, 18-65 year-olds with type 1 diabetes and who are unable to control their blood glucose levels even with the most rigid insulin schedule, will receive transplants of insulin-producing cells in the next 18 months.

Dr. Jeffery Bluestone, director of ITN gives the following for enrollment criteria:

  1. Males and females, 18-65 years of age, diagnosed in last five years with type 1 diabetes who can not control their diabetes with insulin therapy
  2. Do not sense onset of hypoglycemia
  3. Have had at least one hypoglycemic reaction in last 1.6 years that cannot be otherwise explained and required medical attention
  4. Have complications of diabetes such as progressive vision, kidney, nerve or vascular problems despite efforts to control blood glucose levels.
Information for those interested in being a participant can telephone the ITN patient Referral Hotline (773) 834-5341 in the United States and (780) 407-1501 in Canada. Referral forms are to be completed, signed by patient's physician and returned by Jan.1, 2001. Persons who appear to meet the criteria will be contacted for further consultation before a final evaluation. ITN web site at http://www.immunetolerance.org is also available.

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