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[IP] Studies Test New Approaches to Islet Transplantation

 <http://www.niddk.nih.gov/> National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK)
For Immediate Release
Thursday, May 1, 2008 

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<http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress&A=1> Subscribe  
Joan  <mailto:email @ redacted> Chamberlain, NIDDK

NIAID News Office <mailto:email @ redacted> 

Studies Test New Approaches to Islet Transplantation 

Researchers from 11 medical centers in the United States, Canada, Sweden,
and Norway have begun testing new approaches to transplanting clusters of
insulin-producing islets in adults with difficult-to-control type 1
diabetes. The clinical studies, funded by the National Institutes of Health
(NIH), will determine whether changes to current methods of islet
transplantation lead to improved, long-lasting control of blood glucose with
fewer side effects. 

In islet transplantation, clusters of islets are extracted from a donor
pancreas and infused into the recipient's liver. In a successful transplant,
the islets become embedded in the liver and begin producing insulin. 

"A major goal of the NIH research program in type 1 diabetes is to develop
therapies that replace the insulin-producing cells destroyed by the
autoimmune process," said NIH Director Elias A. Zerhouni, M.D. "These
studies, which build on advances in immunology and transplantation research,
may open the door to more widespread use of islet transplantation for
patients with severe type 1 diabetes." 

About 5 percent to 10 percent of the nearly 21 million people with diabetes
have type 1, formerly known as juvenile onset diabetes or insulin-dependent
diabetes. In type 1 diabetes, a person's own immune cells attack and destroy
pancreatic beta cells, which produce the hormone insulin needed for
survival. Beta cells, along with several other types of cells that work
together to balance blood glucose, reside in islets, also known as islets of
Langerhans, in the pancreas. Three or more insulin injections a day or
treatment with an insulin pump are often needed to maintain blood glucose
control, but most people with type 1 diabetes still develop complications,
including damage to the heart and blood vessels, eyes, nerves, and kidneys.
Despite steady improvements in managing the disease, type 1 diabetes cuts
lives short by about 15 years, with early deaths due mainly to heart attacks
and strokes. 

In 2000, a research team led by Dr. James Shapiro at the University of
Alberta in Edmonton, Canada, reported sustained insulin independence in
seven patients transplanted with islets from two to four donor pancreases
and treated with an immunosuppressive regimen that omitted glucocorticoids,
thought to be toxic to islets. In the next few years, other researchers
replicated the "Edmonton protocol," and most centers adopted this approach
to islet transplantation. 

The protocol greatly benefits some patients with severe type 1 diabetes, but
two or more infusions of islets are usually needed, and the islets tend to
lose their insulin-producing function over time. Participating in an islet
transplant study is appropriate for people with severe hypoglycemia
(dangerously low levels of blood sugar) and for those with type 1 diabetes
who have had a kidney transplant to treat kidney failure, a complication of

Since the Edmonton advance, scientists have been working to lengthen the
survival of donor islets and reduce the side effects - such as anemia, nerve
and kidney damage, and vulnerability to infection - of drugs that prevent
the body's destruction of donor islets. In the new studies, the researchers
will culture islets before transplantation to enhance their viability. They
will also compare specific anti-rejection drugs for the ability to maximize
islet survival while reducing toxicity. As the procedure becomes safer and
new sources of beta cells become available, more people are likely to

The researchers are conducting pilot, or phase 1/2, studies of experimental
agents as well as phase 3 studies that modify the Edmonton protocol. If the
phase 3 studies succeed in safely controlling blood glucose levels, the
investigators may ask the Food and Drug Administration to approve the
procedure for people with poorly controlled type 1 diabetes. (For
information about the phases of clinical trials, see

"If these approaches are successful in prolonging islet function with less
drug toxicity, type 1 diabetes patients with severe problems controlling
their blood glucose may have another treatment option for controlling their
diabetes," said study chair Dr. Camillo Ricordi of the University of Miami. 

The studies are enrolling individuals with type 1 diabetes who have serious
difficulty controlling their blood glucose despite intensive medical therapy
and who suffer from episodes of severe hypoglycemia (dangerously low levels
of blood glucose). Also eligible are patients with severe hypoglycemia and
hypoglycemia unawareness, who cannot sense a drop in blood glucose and may
lose consciousness without warning. In addition, researchers are accepting
type 1 diabetes patients who have had a kidney transplant and are already
taking immunosuppressive drugs. For more information about the studies, call
1-877-IsletStudy (1-877-475-387-8839) or see

The following researchers are conducting the studies: 

*	Dr. Camillo Ricordi, study chair 
University of Miami
*	Dr. Christian Larsen 
Emory University, Atlanta
*	Dr. Dixon Kaufman 
Northwestern University, Chicago 
*	Dr. Bernhard Hering 
University of Minnesota, Minneapolis
*	Dr. Ali Naji 
University of Pennsylvania, Philadelphia
*	Dr. Peter Stock 
University of California, San Francisco
*	Dr. James Shapiro 
University of Alberta, Edmonton, Canada
*	Dr. Jose Oberholzer 
University of Illinois at Chicago
*	Dr. Aksel Foss 
University Hospital Rikshospitalet, Oslo, Norway
*	Dr. Olle Korsgren 
Uppsala University Hospital, Uppsala, Sweden
*	Dr. Annika Tibell 
Karolinska University Hospital, Stockholm, Sweden

Dr. William Clarke oversees the Consortium's Data Coordinating Center at the
University of Iowa. 

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
and the National Institute of Allergy and Infectious Diseases (NIAID),
components of the NIH, are sponsoring the studies. The studies are funded by
a special Congressional funding program for type 1 diabetes research,
recently extended through fiscal year 2009, which supplements the regular
NIH appropriation for diabetes research. 

The NIDDK conducts and supports research in diabetes and other endocrine and
metabolic diseases; digestive diseases, nutrition, and obesity; and kidney,
urologic, and hematologic diseases. Spanning the full spectrum of medicine
and afflicting people of all ages and ethnic groups, these diseases
encompass some of the most common, severe, and disabling conditions
affecting Americans. For more information about NIDDK and its programs, see
www.niddk.nih.gov <http://www.niddk.nih.gov/> .

NIAID supports basic and applied research to prevent, diagnose and treat
infectious diseases such as HIV/AIDS and other sexually transmitted
infections, influenza, tuberculosis, malaria and illness from potential
agents of bioterrorism. NIAID also supports research on basic immunology,
transplantation and immune-related disorders, including autoimmune diseases,
asthma and allergies. For more information about NIAID and its programs, see
www.niaid.nih.gov <http://www.niaid.nih.gov/> .

The National Institutes of Health (NIH) - The Nation's Medical Research
Agency - includes 27 Institutes and Centers and is a component of the U.S.
Department of Health and Human Services. It is the primary federal agency
for conducting and supporting basic, clinical and translational medical
research, and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and its programs,
visit www.nih.gov <http://www.nih.gov/> . 

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