Expired Study
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Omaha, Nebraska 68198


Purpose:

We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas. The improvements are: - Using Two-Layer method preservation to improve pancreas quality before islet isolation - Maintaining isolated islets in culture before transplantation - Using a steroid-free immunosuppression regimen - Transplanting the best combination of donor and recipient possible after HLA screening and final crossmatching


Criteria:

Inclusion Criteria: - Group 1: Diagnosis of Type-1 diabetes mellitus for more than 5 years with at least one of the following complications: - Metabolic lability/instability (two or more episodes of severe hypoglycemia) or two or more hospital visits for diabetic ketoacidosis during the previous year - Progression of secondary complications of diabetes as determined by The Nebraska Medical Center/University of Nebraska Medical Center staff endocrinologists - Group 2: Diagnosis of Type-1 diabetes with successful renal transplant on steroid-free, FK506/rapamycin-based immunosuppression Exclusion Criteria: - Severe co-existing cardiac disease - Active alcohol or substance abuse, including cigarette smoking - Psychiatric disorder making the subject not a suitable candidate for transplantation - History of medical non-compliance - Active infection, including hepatitis C and B, HIV, and tuberculosis (or suspected tuberculosis) - Any history of malignancy except squamous or basal cell skin cancer - BMI >28 kg/meter-squared, or body weight >80kg at screening visit, or >85kg on the day of transplantation (due to the difficulty of obtaining a sufficiently large islet mass to adequately treat either large patients or those whose obesity elevates their insulin needs) - Positive C-peptide response to intravenous glucose tolerance test and Mixed Meal glucose tolerance test: any C-peptide >0.3 ng/mL post infusion - Inability to provide informed consent - Age less than 19 or greater than 70 years - Creatinine clearance <60 mL/min/1.73 meter-squared for Group 1 and creatinine clearance <40 mL/min/1.73 meter-squared for Group 2 (those subjects currently on immunosuppression due to previous kidney transplant) - Macroalbuminuria (urinary albumin excretion rate >300 mg/24h) for Group 1 and macroalbuminuria (urinary albumin excretion rate >600mg/24h) for Group 2 - Baseline Hb <10 gm/dL - Baseline liver function tests outside of normal range - Presence of gallstones or hemangioma in liver on baseline ultrasound exam - Positive pregnancy test, intention of future pregnancy, or presently breast-feeding - Evidence of sensitization on PRA - Insulin requirement >0.7 IU/kg/day or HbA1c >15% - Hyperlipidemia - Under treatment for a medical condition requiring chronic use of steroids - Use of Coumadin or other anticoagulant therapy (except aspirin) or PT-INR>1.5 - Diagnosis of Addison's disease Additional Exclusion Criteria for Group 2 Subjects: - Any history of organ transplantation other than kidney or pancreas - Any previous graft lost to rejection - Any history of early, multiple, or vascular renal allograft rejection


NCT ID:

NCT00579371


Primary Contact:

Principal Investigator
R Brian Stevens, MD PhD
University of Nebraska


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68198
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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