| Outcome Measures: |
Primary: Safety- Adverse Events (AE) and Adverse Events of Special Interest (AEoSI), Incidence of adverse events, Accessed from date of transplant through 1 year post transplant for approximately 2 years|Efficacy- Insulin independence, Change in the proportion of participants that become insulin independent at Days 75 and 365 post-first, and final transplant, Days 75 , Day 365 post-first transplant, and final transplant and 1 year after discontinuation of AT-1501 | Secondary: Efficacy- Graft failure, Proportion of participants with graft failure, Day 365|Efficacy- Durability of insulin independence- long term, Change in the proportion of participants that become insulin independent at year 2 and year 3, 2 and 3 years after discontinuation of AT- 1501|Efficacy- HbA1c, * Proportion of participants with HbA1c \<7.0% (53 mmol/mol) and free of serious hypoglycemic events (SHEs) * Proportion of participants with HbA1c ≤6.5% (48 mmol/mol) and free from SHEs, Day 365 and free of serious hypoglycemic events from Day 28 to 365 post-first transplant | Other: Exploratory- Hypoglycemia unawareness (using the method of Clarke), Proportion of participants with hypoglycemia unawareness, Day 75, 365, and 1, 2 and 3 years after discontinuation of AT-1501|Exploratory- Glycemic lability (using CGMS), Change in glycemic lability using CGMS- Continuous Glucose Monitoring System, Day 75, 365, and 1, 2 and 3 years after discontinuation of AT-1501|Exploratory- Glycemic variability (using CGMS), Change in glycemic variability using CGMS- Continuous Glucose Monitoring System, Day 75, 365, and 1, 2 and 3 years after discontinuation of AT-1501|Exploratory- Albumin excretion ratio (AER), Change in albumin excretion ratio (AER), Day 365 post-first, and final transplant|Exploratory- eGRF, Change in eGRF, Day 365 post-first, and final transplant|Exploratory- Macroalbuminemia, Change in percent new macroalbuminemia, Day 365 post-first, and final transplant|Exploratory- biomarkers of tissue damage and inflammation, Biomarkers, Day -2, 3, 14, 28, 75, 175, 364|Exploratory -Pharmacokinetic Parameters-AUC, Pharmacokinetics (PK) of AT-1501, T=0 (pre infusion), 1 (end of infusion), 2, 4, 8, 12, 24 and 48 hrs.|Exploratory- Pharmacokinetic Parameters-Cmax, Pharmacokinetics (PK) of AT-1501, T=0 (pre infusion), 1 (end of infusion), 2, 4, 8, 12, 24 and 48 hrs.|Exploratory- Pharmacokinetic Parameters-CL, Pharmacokinetics (PK) of AT-1501, T=0 (pre infusion), 1 (end of infusion), 2, 4, 8, 12, 24 and 48 hrs.|Exploratory- Pharmacokinetic Parameters- Vdss, Pharmacokinetics (PK) of AT-1501, T=0 (pre infusion), 1 (end of infusion), 2, 4, 8, 12, 24 and 48 hrs.|Exploratory- Pharmacokinetic Parameters- (t1/2), Pharmacokinetics (PK) of AT-1501, T=0 (pre infusion), 1 (end of infusion), 2, 4, 8, 12, 24 and 48 hrs.
|
