Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
Conditions
Brief summary
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
Interventions
BIOLOGICALAllogeneic Human E-islet (E-islet 01)
Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein
Sponsors
EndoCell Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical history of Type 1 Diabetes with \> 5 years of duration * 2-hour C-peptide level \<0.3 ng/mL after a mixed meal stimulation test * Under continuous insulin therapy, Participants have at least one of the following conditions: 1. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment; 2. Unaware hypoglycemia evaluated using the Clarke scoring system * Willing and able to conduct self-blood glucose monitoring as required, with good compliance * Voluntarily participate and sign the informed consent form
Exclusion criteria
* Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab). * History of malignancy within the past 5 years or undergoing antitumor treatment * Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment * Other situations judged by the investigator as unsuitable for participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 | At 1 year after E-islet 01 infusion |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants who are Time in range (TIR) >70% | At 1 year after E-islet 01 infusion |
| Number of participants with increase in fasting C-peptide and stimulated C-peptide from baseline | At 1 year after E-islet 01 infusion |
| Proportion of Participants who are Insulin Independent or Reduction in Exogenous Insulin | At 1 year after E-islet 01 infusion |
Countries
China
Contacts
Primary Contactyanyan ma
Outcome results
None listed