The Clinical Trials Statistical and Data Management Center (CTSDMC) in the Department of Biostatistics, College of Public Health at The University of Iowa in collaboration with the Department of Internal Medicine proposes to establish and operate the Data Coordinating Center (DCC) for the Clinical Islet Transplantation: Data Coordinating Center (RFA -DK-04-004). This CTSDMC will work with the study clinical centers, and NIH to develop and execute important clinical investigations to help address the consortium's goals to develop and execute important mechanistic and clinical investigations to understand and improve islet cell transplantation in patients with type I diabetes. We will use our study design, statistical, data management, and study coordination experience and expertise to help the consortium examine ways to (1) increasing the efficiency of islet transplantation; (2) improving immunotherapy to reduce toxicity, recurrent autoimmunity and allograft rejection; and (3) to develop interventions to reduce the local complications of the islet administration procedure. Our group brings over 30 years of experience in the design and implementation clinical and epidemiology studies and over 14 years experience serving as the data coordinating center for multi-center clinical trials. These studies include studies in neurology, nephrology, and diabetes. We represent an experienced and productive team of investigators who have worked together for many years. The CTSDMC staff has; successfully developed and operated web based data entry systems and databases for multi-center trials and have an excellent record in successfully coordinating clinical trials.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK070431-04
Application #
7285959
Study Section
Special Emphasis Panel (ZDK1-GRB-N (O2))
Program Officer
Eggerman, Thomas L
Project Start
2004-09-30
Project End
2009-07-31
Budget Start
2007-08-01
Budget End
2008-07-31
Support Year
4
Fiscal Year
2007
Total Cost
$3,702,030
Indirect Cost
Name
University of Iowa
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
von Zur-Mühlen, Bengt; Lundgren, Torbjörn; Bayman, Levent et al. (2018) Open Randomized Multicenter Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation. Transplantation :
Rickels, M R; Markmann, E; Naji, A (2018) Successful pregnancies after islet transplantation for type 1 diabetes. Am J Transplant :
Foster, Eric D; Bridges, Nancy D; Feurer, Irene D et al. (2018) Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care 41:1001-1008
Hanley, Patrick; Sutter, Jennifer A; Goodman, Noah G et al. (2017) Circulating B cells in type 1 diabetics exhibit fewer maturation-associated phenotypes. Clin Immunol 183:336-343
Hering, Bernhard J; Bridges, Nancy D; Eggerman, Thomas L et al. (2017) Comment on Harlan. Islet Transplantation for Hypoglycemia Unawareness/Severe Hypoglycemia: Caveat Emptor. Diabetes Care 2016;39:1072-1074. Diabetes Care 40:e111-e112
Vallabhajosyula, Prashanth; Korutla, Laxminarayana; Habertheuer, Andreas et al. (2017) Tissue-specific exosome biomarkers for noninvasively monitoring immunologic rejection of transplanted tissue. J Clin Invest 127:1375-1391
Eriksson, Olof; Selvaraju, Ramkumar; Eich, Torsten et al. (2016) Positron Emission Tomography to Assess the Outcome of Intraportal Islet Transplantation. Diabetes 65:2482-9
Rickels, Michael R; Peleckis, Amy J; Markmann, Eileen et al. (2016) Long-Term Improvement in Glucose Control and Counterregulation by Islet Transplantation for Type 1 Diabetes. J Clin Endocrinol Metab 101:4421-4430
Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N et al. (2016) National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 65:3418-3428
Hering, Bernhard J; Clarke, William R; Bridges, Nancy D et al. (2016) Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care 39:1230-40

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