Recruiting NCT07126873
A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allogeneic Human E-islet (E-islet 01).
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
Overview
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
- Biological Allogeneic Human E-islet (E-islet 01)
Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein
Primary outcome measures
- Safety 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]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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:
- At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Changzheng Hospital — Shanghai
Identifiers
NCT: NCT07126873 · ENDOCELL-T1DM-101