Outcome Measures: |
Primary: To demonstrate AAT efficacy in preventing non-immunologic loss of transplanted islet mass in a single-donor islet transplant., Insulin independence at day 90 post-transplant (initial, single-donor transplant), Day 90 post-transplant | Secondary: To demonstrate safety of AAT during islet isolation and culture, Post-isolation measurements, compared to current standard protocol isolation data, for the following parameters: * Endotoxin level * Microbiological culture \[bacterial (both aerobic and anaerobic), fungal, mycoplasma, and mycobacterium culture\], Day -1 pre-transplant|To demonstrate efficacy of AAT to improve islet isolation quantity and quality, Post-isolation measurements, compared to current standard protocol isolation data, for the following parameters: * Islet yield * Viability (SytoGreen/ethidium bromide) * Purity * Beta cell specific viability * Cell composition assay * Glucose stimulated insulin release * DNA content, Day -1 pre-transplant|To demonstrate safety of AAT in islet transplantation., Adverse Event/Serious Adverse Event morbidity within 1 year post-transplant, which includes the following: * Primary non-function (PNF) * End-organ dysfunction * Malignancy * Opportunistic infection * Inpatient hospitalization * Prolongation of existing hospitalization * A life-threatening event * Persistent or significant disability * Congenital anomaly or birth defect * Patient death, Year 1 post-transplant|To demonstrate AAT efficacy in the prevention of long-term metabolic burn-out., * Full graft function at 1 year after initial single-donor transplant, compared to retrospective controls (current standard of care induction). * Partial graft function at 1 year after initial single-donor transplant compared to retrospective controls (current standard of care induction)., Year 1 post-transplant
|