NIDDK Office of Communications
NIH announces new clinical trials of promising transplant
therapy for diabetes (Edmonton islet cell transplantation
NIH-NIDDK Press Release
(Jul) 00:July 13, 2000
NIH Announces New Clinical Trials of Promising
Transplant Therapy for
|FOR IMMEDIATE RELEASE|
Thursday, July 13, 2000
NIAID Office of Communications and Public Liaison
Greg Roa, (301) 402-1663
NIDDK Office of Communications and Public Liaison
Joan Chamberlain, (301) 496-3583
Ten research centers will soon begin testing a promising technique for
transplanting insulin-producing pancreas cells that may one day allow people
with type 1 diabetes to stop their insulin shots. Known as the "Edmonton
protocol," the experimental technique is among the first to be carried out
in the $144 million Immune Tolerance Network (ITN), an international
consortium of clinical researchers dedicated to developing approaches to
induce immune "tolerance." If successful, these approaches will selectively
modulate the immune system to inhibit harmful immune responses while keeping
protective ones intact.
The ITN is a seven-year effort spearheaded 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 dollars to expand studies
of the Edmonton protocol in centers located in Edmonton, Alberta (Canada),
Miami, Minneapolis, Boston, St. Louis, Seattle, and Bethesda, Maryland.
Additional European sites are planned in Geneva, Switzerland, Giessen,
Germany, and Milan, Italy. Approximately 40 patients-18 to 65 year-olds who
have type 1 (juvenile) diabetes and are unable to control their blood sugar
with even the most rigid insulin schedule-will receive transplants of the
insulin-producing pancreas cells, known as islets, in the next 18 months.
"This trial will serve as a platform for future ITN studies to investigate
new 'tolerance therapies,' treatments that may replace the life-long
immunosuppressive drugs that transplant recipients currently require to
maintain functioning islets," says NIAID Director Dr. Anthony S. Fauci.
The Edmonton protocol was developed by Dr. James Shapiro and colleagues at
the University of Alberta. In a journal article last month, Dr. Shapiro and
his colleagues reported reversing dependence on insulin injection in seven
diabetic patients. The ITN will expand those studies to larger numbers of
patients and investigate the underlying immunologic mechanisms at work
following islet transplantation.
"While we have known for nearly a decade that tight control of blood glucose
delays or prevents diabetes complications, many people have great difficulty
achieving optimal control with current treatment methods. Islet
transplantation offers the potential for gaining such control and arresting
complications," says NIDDK Director Dr. Allen Spiegel.
NIH, which participates in the ITN, will be attempting to duplicate the
Edmonton results. Rather than suppressing the body's entire immune system,
tolerance therapies specifically block just those immune responses that
destroy a person's own tissues or cause them to reject transplanted tissues.
Several promising tolerogenic approaches are now under investigation.
"The ITN clinical trials represent a very significant step forward in
diabetes research, and we hope to someday make this approach available to
all people with diabetes," says Dr. Jeffrey Bluestone, director of the ITN.
Patient Enrollment Criteria and Procedures
Males and females between the ages of 18 to 65 who were diagnosed with type
I diabetes at least five years ago and who:
- cannot control their blood sugar even with intensive insulin therapy
- do not adequately sense the onset of hypoglycemia (low blood sugar)
- have had a least one hypoglycemic reaction in the last 1.6 years that
cannot be otherwise explained and required medical attention
- have secondary complications of diabetes, such as progressive vision,
kidney, nerve or vascular problems despite efforts to optimize control of
More information for patients wishing to participate is available on the ITN
Web site at http://www.immunetolerance.org
or from the ITN Patient Referral Hotline at (773) 834-5341 in the United
States. Canadian residents may phone (780) 407-1501. Referral forms are to
be completed, signed by the patient's physician and returned by January 1,
2001. Patients who appear to meet all the criteria will be contacted for
further consultation prior to a final evaluation.
- University of Alberta Clinical Islet Transplantation Program, Edmonton,
- Diabetes Research Institute, University of Miami, Miami, Florida
- Diabetes Institute for Immunology and Transplantation, University of
Minnesota, Minneapolis, Minnesota
- Juvenile Diabetes Foundation Center for Islet Transplantation, Harvard
Medical School, Boston, Massachusetts
- Diabetes Research Training Center, Washington University, St. Louis,
- Pacific Northwest Research Institute, Seattle, Washington
- Organ/Tissue Transplant Research Center, National Institutes of Health,
- Islet Transplant Centre, Justis-Liebig University, Giessen, Germany
- San Raffaele Scientific Institute, University of Milan, Milan, Italy
- University Hospital, Geneva, Switzerland
Press releases, fact sheets and other NIAID-related materials are available
on the NIAID Web site at http://www.niaid.nih.gov.
The National Institute of Allergy and Infectious Diseases is a component
the National Institutes of Health, U.S. Department of Health and Human