| Outcome Measures: |
Primary: Insulin independence, off insulin therapy for at least 1 week and all of the following criteria are met: * HbA1c \< 6.5% or a \> 2.5% decrease from baseline; * Daily fasting capillary glucose should not exceed 140 mg/dL (7.8 mmol/L) more than 3 times in the past week; * 2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week; * Fasting plasma glucose \< 126 mg/dL (7.0 mmol/L); if the fasting plasma glucose is \> 126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements; Protocol Version 4.0 December 19, 2017 39 * Evidence of endogenous insulin production defined as fasting or stimulated C-peptide \>0.5 ng/mL (0.16 nmol/L)., 75 days after the first transplant|Insulin independence, off insulin therapy for at least 1 week and all of the following criteria are met: * HbA1c \< 6.5% or a \> 2.5% decrease from baseline; * Daily fasting capillary glucose should not exceed 140 mg/dL (7.8 mmol/L) more than 3 times in the past week; * 2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week; * Fasting plasma glucose \< 126 mg/dL (7.0 mmol/L); if the fasting plasma glucose is \> 126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements; Protocol Version 4.0 December 19, 2017 39 * Evidence of endogenous insulin production defined as fasting or stimulated C-peptide \>0.5 ng/mL (0.16 nmol/L)., 1 year after the first transplant|Insulin independence, off insulin therapy for at least 1 week and all of the following criteria are met: * HbA1c \< 6.5% or a \> 2.5% decrease from baseline; * Daily fasting capillary glucose should not exceed 140 mg/dL (7.8 mmol/L) more than 3 times in the past week; * 2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week; * Fasting plasma glucose \< 126 mg/dL (7.0 mmol/L); if the fasting plasma glucose is \> 126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements; Protocol Version 4.0 December 19, 2017 39 * Evidence of endogenous insulin production defined as fasting or stimulated C-peptide \>0.5 ng/mL (0.16 nmol/L)., 1 year after the last transplant | Secondary: Changes in HbA1c, Proportion of subjects with an HbA1c \<7.0% and free of severe hypoglycemic events from day 28 to 365 after the first and final islet transplant, From day 28 to 365|Changes (reduction) in insulin requirements, decrease of insulin dose as compared to pre-transplantation of islets, up to 5 years|Incidence of adverse events, the incidence of AEs related to the transplant procedure or immunosuppression, up to 5 years
|
