MEDICAL: DISEASES: DIABETES : MEDICAL: RESEARCH: Studies Test New Approaches to Islet Transplantation AND MORE

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MEDICAL: DISEASES: DIABETES :
MEDICAL: RESEARCH:
Studies Test New Approaches to Islet Transplantation AND MORE

Date: Fri, 2 May 2008 08:33:35 -0400
From: "NIH OLIB (NIH/OD)" <ol...@OD.NIH.GOV>
To: NIHP...@LIST.NIH.GOV
Subject: Studies Test New Approaches to Islet Transplantation

STUDIES TEST NEW APPROACHES TO ISLET TRANSPLANTATION

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
<http://www.niddk.nih.gov/>

For Immediate Release: Thursday, May 1, 2008

CONTACT:
Joan Chamberlain, NIDDK

301-496-3583

e-mail:

niddk...@mail.nih.gov

NIAID News Office

301-402-1663

e-mail: niai...@nih.gov

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 diabetes.

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 benefit.

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

<http://www.fda.gov/fdac/features/2003/503_trial.html>

"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

<http://www.citisletstudy.org/index.html>

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>

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

<http://www.niaid.nih.gov>

The National Institutes of Health (NIH) - The Nation's Medical Research
Agency - is comprised of 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 investigates the causes, treatments,
and cures for both common and rare diseases. For more information about
NIH and its programs, visit

<http://www.nih.gov>

This NIH News Release is available online at:

<http://www.nih.gov/news/health/may2008/niddk-01.htm>

End of NIH Press Release

----------------------------------

Islet Transplantation in Seven Patients with Type 1 Diabetes Mellitus
Using a Glucocorticoid-Free Immunosuppressive Regimen
A.M. James Shapiro, M.B., B.S., Jonathan R.T. Lakey, Ph.D., Edmond A.
Ryan, M.D., Gregory S. Korbutt, Ph.D., Ellen Toth, M.D., Garth L. Warnock,
M.D., Norman M. Kneteman, M.D., and Ray V. Rajotte, Ph.D.
The New England Journal of Medicine
Volume 343:230-238 July 27, 2000 Number 4
<http://content.nejm.org/cgi/content/brief/343/4/230>

Clinical Outcomes and Insulin Secretion After Islet Transplantation With
the Edmonton Protocol
Edmond A. Ryan1, Jonathan R.T. Lakey2, Ray V. Rajotte2, Gregory S.
Korbutt2, Tatsuya Kin2, Sharleen Imes4, Alex Rabinovitch1, John F.
Elliott3, David Bigam2, Norman M. Kneteman2, Garth L. Warnock2, Ingrid
Larsen4, and A.M. James Shapiro2
Diabetes 50:710-719, 2001
the American Diabetes Association, Inc.
<http://diabetes.diabetesjournals.org/cgi/content/abstract/50/4/710>

Successful Islet Transplantation
Continued Insulin Reserve Provides Long-Term Glycemic Control
Edmond A. Ryan1, Jonathan R.T. Lakey2,3, Breay W. Paty1, Sharleen Imes4,
Gregory S. Korbutt3, Norman M. Kneteman2, David Bigam2, Ray V. Rajotte3,
and A.M. James Shapiro2
Diabetes 51:2148-2157, 2002
<http://diabetes.diabetesjournals.org/cgi/content/abstract/51/7/2148>

Five-Year Follow-Up After Clinical Islet Transplantation
Edmond A. Ryan1, Breay W. Paty1, Peter A. Senior1, David Bigam2, Eman
Alfadhli1, Norman M. Kneteman2, Jonathan R.T. Lakey2, and A.M. James
Shapiro2
Diabetes 54:2060-2069, 2005
<http://diabetes.diabetesjournals.org/cgi/content/abstract/54/7/2060?ct>

Insulin independence in a type 1 diabetic patient after encapsulated islet
transplantation.
Soon-Shiong P, Heintz RE, Merideth N, Yao QX, Yao Z, Zheng T, Murphy M,
Moloney MK, Schmehl M, Harris M, et al.
St Vincent Medical Center, Los Angeles, CA 90057.
Lancet. 1994 Apr 16;343(8903):950-1

Immunosuppressive effects of human CTLA4Ig in a non-human primate model of
allogeneic pancreatic islet transplantation
MG Levisetti, PA Padrid, GL Szot, N Mittal, SM Meehan, CL Wardrip, GS
Gray, DS Bruce, JR Thistlethwaite Jr and JA Bluestone
Department of Surgery, University of Chicago, IL 60637, USA.
The Journal of Immunology, Vol 159, Issue 11 5187-5191,
Copyright 1997 by American Association of Immunologists
<http://www.jimmunol.org/cgi/content/abstract/159/11/5187>

Autologous islet transplantation to prevent diabetes after pancreatic
resection.
D C Wahoff, B E Papalois, J S Najarian, D M Kendall, A C Farney, J P
Leone, J Jessurun, D L Dunn, R P Robertson, and D E Sutherland
Department of Surgery, University of Minnesota, Minneapolis, USA.
Ann Surg. 1995 October; 222(4): 562579.
Annals of Surgery
<http://www.pubmedcentral.nih.gov/articlerender.fcgi?&artid=1234892>

Incompatibility between human blood and isolated islets of Langerhans: a
finding with implications for clinical intraportal islet transplantation?
Bennet W, Sundberg B, Groth CG, Brendel MD, Brandhorst D, Brandhorst H,
Bretzel RG, Elgue G, Larsson R, Nilsson B, Korsgren O.
Department of Transplantation Surgery, Karolinska Institutt, Huddinge
Hospital, Sweden. william...@transpl.hs.sll.se
Diabetes. 1999 Oct;48(10):1907-14
<http://www.ncbi.nlm.nih.gov/pubmed/10512353>

Insulin independence after islet transplantation into type I diabetic
patient.
Scharp DW, Lacy PE, Santiago JV, McCullough CS, Weide LG, Falqui L,
Marchetti P, Gingerich RL, Jaffe AS, Cryer PE, et al.
Human Islet Transplant Center, Washington University Medical Center,
Barnes Hospital, St. Louis, Missouri.
Diabetes. 1990 Apr;39(4):515-8

Bone marrow augmentation of donor-cell chimerism in kidney, liver, heart,
and pancreas islet transplantation.
Fontes P, Rao AS, Demetris AJ, Zeevi A, Trucco M, Carroll P, Rybka W,
Rudert WA, Ricordi C, Dodson F, et al.
Department of Surgery, Pittsburgh Transplant Institute, University of
Pittsburgh Medical Centre, PA 15213.
Lancet. 1994 Jul 16;344(8916):151-5

Islet Transplantation as a Treatment for Diabetes A Work in Progress
R. Paul Robertson, M.D.
Volume 350:694-705 February 12, 2004 Number 7
The New England Journal of Medicine
<http://content.nejm.org/cgi/content/extract/350/7/694>

Scientific and political impediments to successful islet transplantation.
Weir GC, Bonner-Weir S.
Research Division, Joslin Diabetes Center, Boston, MA 02215, USA.
we...@joslab.harvard.edu
Diabetes. 1997 Aug;46(8):1247-56
<http://www.ncbi.nlm.nih.gov/pubmed/9231647>

Human Pancreatic Islets Produce and Secrete MCP-1/CCL2: Relevance in Human
Islet Transplantation
Lorenzo Piemonti1, Biagio Eugenio Leone2, Rita Nano1, Alessandra Saccani3,
Paolo Monti1, Paola Maffi4, Giancarlo Bianchi3, Antonio Sica3, Giuseppe
Peri3, Raffaella Melzi1, Luca Aldrighetti1, Antonio Secchi4, Valerio Di
Carlo1, Paola Allavena3, and Federico Bertuzzi1
Diabetes 51:55-65, 2002
<http://diabetes.diabetesjournals.org/cgi/content/abstract/51/1/55>

Single-Donor, Marginal-Dose Islet Transplantation in Patients With Type 1
Diabetes
Bernhard J. Hering, MD; Raja Kandaswamy, MD; Jeffrey D. Ansite, BS; Peter
M. Eckman, MD; Masahiko Nakano, MD, PhD; Toshiya Sawada, MD; Ippei
Matsumoto, MD, PhD; Sung-Hee Ihm, MD; Hui-Jian Zhang, MD; Jamen Parkey,
PA-C, MPH; David W. Hunter, MD; David E. R. Sutherland, MD, PhD
JAMA. 2005;293:830-835.
<http://jama.ama-assn.org/cgi/content/abstract/293/7/830>

Production of tissue factor by pancreatic islet cells as a trigger
of detrimental thrombotic reactions in clinical islet transplantation .
The Lancet , Volume 360 , Issue 9350 , Pages 2039 - 2045
L . Moberg , H . Johansson , A . Lukinius , C . Berne , A . Foss , R
. Kllen , . straat , K . Salmela , A . Tibell , G . Tufveson

International Trial of the Edmonton Protocol for Islet Transplantation
A.M. James Shapiro, M.D., Ph.D., Camillo Ricordi, M.D., Bernhard J.
Hering, M.D., Hugh Auchincloss, M.D., Robert Lindblad, M.D., R. Paul
Robertson, M.D., Antonio Secchi, M.D., Mathias D. Brendel, M.D., Thierry
Berney, M.D., Daniel C. Brennan, M.D., Enrico Cagliero, M.D., Rodolfo
Alejandro, M.D., Edmond A. Ryan, M.D., Barbara DiMercurio, R.N., Philippe
Morel, M.D., Kenneth S. Polonsky, M.D., Jo-Anna Reems, Ph.D., Reinhard G.
Bretzel, M.D., Federico Bertuzzi, M.D., Tatiana Froud, M.D., Raja
Kandaswamy, M.D., David E.R. Sutherland, M.D., Ph.D., George Eisenbarth,
M.D., Ph.D., Miriam Segal, Ph.D., Jutta Preiksaitis, M.D., Gregory S.
Korbutt, Ph.D., Franca B. Barton, M.S., Lisa Viviano, R.N., Vicki
Seyfert-Margolis, Ph.D., Jeffrey Bluestone, Ph.D., and Jonathan R.T.
Lakey, Ph.D.
Volume 355:1318-1330 September 28, 2006 Number 13
The New England Journal of Medicine
<http://content.nejm.org/cgi/content/abstract/355/13/1318>

Pancreas and islet transplantation for patients with diabetes.
Robertson RP, Davis C, Larsen J, Stratta R, Sutherland DE.
Pacific Northwest Research Institute, and the University of Washington,
Seattle 98122, USA. r...@u.washington.edu
Diabetes Care. 2000 Jan;23(1):112-6

HUMAN ISLET TRANSPLANTATION: Lessons from 13 Autologous and 13 Allogeneic
Transplantations1, 2.
Clinical Transplantation
Transplantation. 69(6):1115-1123, March 27, 2000.
Oberholzer, Jose 3; Triponez, Frederic; Mage, Raymond; Andereggen,
Elisabeth; Buhler, Leo; Cretin, Nathalie; Fournier, Beatrice; Goumaz,
Claudine 4; Lou, Jinning; Philippe, Jacques 5; Morel, Philippe
<http://www.transplantjournal.com/pt/re/transplantation/abstract.00007890-
200003270-00016.htm;jsessionid=LcppplRQwc1mT0wppnfMFWyXCwfwPvrvtdj9f6sn
GVW4N99TQC1m!1379360954!181195629!8091!-1>

A shorter URL for the above link:

<http://tinyurl.com/5kuplb>

Intrahepatic Islet Transplantation in Type 1 Diabetic Patients Does Not
Restore Hypoglycemic Hormonal Counterregulation or Symptom Recognition
After Insulin Independence
Breay W. Paty1,2, Edmond A. Ryan1, A.M. James Shapiro1, Jonathan R.T.
Lakey1, and R. Paul Robertson2
Diabetes 51:3428-3434, 2002
<http://diabetes.diabetesjournals.org/cgi/content/abstract/51/12/3428>

Emerging Treatments and Technologies
Original Article
Benefits and Risks of Solitary Islet Transplantation for Type 1 Diabetes
Using Steroid-Sparing Immunosuppression
The National Institutes of Health experience
Boaz Hirshberg, MD1, Kristina I. Rother, MD1, Benigno J. Digon, III, MD1,
Janet Lee, MD2, Jason L. Gaglia, MD1, Kenneth Hines, BS, MT (ASCP)2,
Elizabeth J. Read, MD2, Richard Chang, MD3, Bradford J. Wood, MD3 and
David M. Harlan, MD1
Diabetes Care 26:3288-3295, 2003
<http://care.diabetesjournals.org/cgi/content/abstract/26/12/3288>

CLINICAL ISLET TRANSPLANTATION: ADVANCES AND IMMUNOLOGICAL CHALLENGES
Camillo Ricordi* and Terry B. Strom
NATURE REVIEWS | IMMUNOLOGY VOLUME 4 | APRIL 2004 | 259
<http://www.diabetesresearch.org/NR/rdonlyres/A5FF8926-8D8E-4EEF-83B3-
F40486D70B42/0/ClinIsletTransAdvancesNatureReviewsImmunology2004.pdf>

A shorter URL for the above link:

<http://tinyurl.com/5foboy>

Insulin Independence Following Isolated Islet Transplantation and Single
Islet Infusions.
SCIENTIFIC PAPERS OF THE SOUTHERN SURGICAL ASSOCIATION
Annals of Surgery. 237(6):741-750, June 2003.
Markmann, James F. MD, PhD *; Deng, Shaoping MD, PhD *; Huang, Xiaolun MD
*; Desai, Niraj M. MD *; Velidedeoglu, Ergun H. MD *; Lui, Chengyang MD *;
Frank, Adam MD *; Markmann, Eileen RN *; Palanjian, Maral RN *; Brayman,
Kenneth MD *; Wolf, Bryan MD, PhD ++; Bell, Ewan MD ++; Vitamaniuk, Marko
PhD +; Doliba, Nicolai PhD +; Matschinsky, Franz PhD +; Barker, Clyde F.
MD *; Naji, Ali MD, PhD *
<http://www.annalsofsurgery.com/pt/re/annos/abstract.
00000658-200306000-00001.htm;jsessionid=LcqP1bppxQGG0
jZDYphpKP34wr2p1jL6VVpYySGQpJTqsfnnHxQh!-1858829228!181195628!8091!-1>

A shorter URL for the above link:

<http://tinyurl.com/5tekcx>

Lilly Lecture 2002
Islet Transplantation: A Brave New World
from Diabetes
Posted 07/09/2003
Camillo Ricordi
<http://www.medscape.com/viewarticle/458047?mpid=16004>

-----------------------------------

Please note there is a very sizable body of literature on this topic and
this bibliography is intended only as a starting point for those
interested in this treatment for diabetes. The URLs provided cite the web
location for the journal article, but may not provide a free source for
access to the article or to additional information about the article
without fee payment and / or subscription to the journal.

Those wishing to find the articles cited in a library, if unavailable full
text on the internet, please consider using WorldCat.

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In the title box type or paste in the JOURNAL title, NOT the ARTICLE
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Sample Search and Sample Results.

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Results 1-10 of about 35 (3.45 seconds)

1.
The New England journal of medicine.
by Massachusetts Medical Society.
Language: English Type: Serials / Magazines / Newspapers : Periodical :
Weekly Internet Resource Internet Resource
Publisher: Boston, Massachusetts Medical Society.

2.
New England journal of medicine.
Language: English Type: Serials / Magazines / Newspapers : Periodical :
Monthly
Publisher: Waltham, Mass. : NEJM, 1986.

3.
The New England journal of medicine and surgery
by Walter Channing; John Ware
Language: English Type: Serials / Magazines / Newspapers : Periodical :
Quarterly (every 3 months) : Microform Microform
Publisher: [Boston, Mass. : T.B. Wait and Co.], 1812-1826.

4.
The New England journal of medicine.
by Massachusetts Medical Society.
Language: English Type: Serials / Magazines / Newspapers : Periodical :
Weekly
Publisher: Melbourn, Royston, Herts. : Massachusetts Medical Society,

5.
The New England journal of medicine and surgery.
Language: English Type: Serials / Magazines / Newspapers : Periodical :
Quarterly (every 3 months) Internet Resource Internet Resource
Publisher: Boston : T.B. Wait and Co., 1812-1826.

6.
Reprints from the New England journal of medicine
Language: English Type: Serials / Magazines / Newspapers
Publisher: Boston, Mass. : The Dept., 1974? - 1976?

7.
The New England journal of medicine. Cumulative index.
by Arnold Aberman
Language: English Type: Serials / Magazines / Newspapers : Periodical
Publisher: Toronto : Cumulative Index Corp, 1968-

8.
Drug therapy from the New England journal of medicine.
Language: English Type: Serials / Magazines / Newspapers
Publisher: [Boston] Massachusetts Medical Society, 1976-

9.
Medical progress annual... A series of ...reports...published...in the New
England journal of medicine...
by Robert Nason Nye
Language: English Type: Serials / Magazines / Newspapers : Annual
Publisher: Springfield, Ill. Baltimore, Md., C.C. Thomas, 1940-42.

10.
Drug therapy from the New England journal of medicine.
by Massachusettes Medical Society.
Language: English Type: Serials / Magazines / Newspapers : Periodical
Publisher: [Massachusettes] : Massachusetts Medical Society, 1976-

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This display, excerpted here, results:

The New England journal of medicine.
by Massachusetts Medical Society.
Type: Serials / Magazines / Newspapers; English
Publisher: Boston, Massachusetts Medical Society.
Editions: 10 Editions
ISSN: 0028-4793
OCLC: 1587974
Related Subjects: Medicine -- Periodicals. | Surgery -- Periodicals.
| Medicine -- Periodicals. | More Subjects ...
Web Resources: nejm.org
Citations: Cite this Item | Export to EndNote | Export to RefWorks

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