This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSafety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From E-islet 01 infusion to end of study (up to 5 years)
Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycated Haemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in Glycosylated hemoglobin(HbA1c) From Baseline
Time frame: At 1 year after E-islet 01 infusion
Proportion of Participants who are Time in range (TIR) >70%
Time frame: At 1 year after E-islet 01 infusion
Number of participants with increase in fasting C-peptide and stimulated C-peptide from baseline
Time frame: At 1 year after E-islet 01 infusion
Proportion of Participants who are Insulin Independent or Reduction in Exogenous Insulin
Time frame: At 1 year after E-islet 01 infusion
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