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Clinical Islet Transplantation Study (CIT)

T1D is an autoimmune disease characterized by the destruction of the insulin-secreting beta cells of the pancreas by cytotoxic T cells. T1D can be difficult to control with currently available therapies. Life threatening and altering consequences are major problems for some patients with T1D including hypoglycemia, accelerated cardiovascular and peripheral vascular diseases, nephropathy, retinopathy, neuropathy, oral diseases and premature death. The incidence of T1D appears to be increasing worldwide. Although the disease may occur at any age, onset peaks prior to twenty years of age. In some populations, approximately one percent of all newborns will develop T1D during their lifetime.

Islet transplantation as a therapy for T1D has been an important focus of NIH support, and significant progress has occurred in recent years. In particular, the success of the "Edmonton Protocol" for islet transplantation in freeing individuals with T1D from the need for insulin therapy has established islet transplantation as an alternative therapy for those T1D patients whose disease cannot be effectively managed with current methods of exogenous insulin administration. However, significant obstacles remain for development of islet transplantation as a treatment for T1D in the general population, most notably the toxicity associated with current regimens of immunosuppression and islet administration and the limited supply of human cadaveric islets, which is sufficient for only a small fraction of the people who could potentially benefit from this therapy. The recent successes in islet transplantation provide additional impetus for research to develop methods to attain an unlimited supply of islets for transplantation; to improve methods for harvesting pancreata and isolating islets; to improve techniques for the administration of transplanted islets; and to develop approaches to minimize the toxicity of immunotherapy required for transplantation.

Objectives and Scope of the CIT Consortium and Trials
The seven CIT clinical trials are:

CIT-01:   Open Randomized Multi-Center Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation (Nordic countries)

CIT-02:   Strategies to Improve Long Term Islet Graft Survival (University of Miami and University of Illinois, Chicago)

CIT-03:   Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes (University of California San Francisco, University of Minnesota, Northwestern University)

CIT-04:   Islet Transplantation in Type 1 Diabetes with LEA29Y (belatacept) Maintenance Therapy (University of Alberta, Emory University)

Cit-05:   B-Lymphocyte Immunotherapy in Islet Transplantation: Toward Calcineurin Inhibitor Free Immunosuppression (University of Pennsylvania)

CIT-06:   Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients: Efficacy of Islet After Kidney Transplantation (all North American sites)

CIT-07:   Islet Transplantation in Type 1 Diabetes (all North American sites)

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