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Public access site: www.CITIsletStudy.org

CIT Status Report Nov. 2014 (pdf)

CIT-06 protocol (pdf)

CIT-07 protocol (pdf)

CIT-07 Statistical Analysis Plan (pdf)

CIT Ancillary Studies policy (pdf)

CIT Site Qualification Criteria (pdf)

CIT Manufacturing Qualification Criteria (pdf)

Terminology Criteria for Adverse Events (TCAE)

Metabolic Testing synopsis (pdf)

Master Production Batch Record (Aug 2011) (.pdf)

Test Release Method SOPs

Type-1 Diabetes Clinical Trial Background
Insulin-dependent diabetes mellitus, or Type-1 diabetes (T1D) is an autoimmune disease characterized by the destruction of the insulin-secreting beta cells of the pancreas. T1D is difficult to control with the current therapies available, and as a result patients may suffer devastating consequences including accelerated cardiovascular and peripheral vascular diseases, nephropathy, retinopathy, neuropathy, oral diseases and premature death. The incidence of T1D appears to be increasing worldwide. Islet transplantation as a therapy for T1D has been an important focus of governmental funding, and significant research progress has occurred in recent years. Islet transplantation is a procedure performed on select patients with Type-1 diabetes to replace insulin-producing cells destroyed by the disease and restore normal blood sugar levels. 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 a realistic therapy for those T1D patients whose disease cannot be effectively managed with current methods of insulin administration.

Clinical Islet Transplantation Trial
This islet transplantation trial, supported by the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID), and Juvenile Diabetes Research Foundation (JDRF), will continue fostering development of islet transplantation as a cure for T1D. Selected patients with Type-I diabetes who have received a successful kidney transplant may be excellent candidates for islet transplantation. It is the aim of this new trial to improve methods of isolating islets, to improve techniques for the administering those transplanted islets; and to develop approaches to minimize the toxic effects of immunosuppressive drugs required for transplantation.