Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
NCT ID:
NCT07142161
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 1 diabetes presenting with any of the following conditions:
Impaired hypoglycemia awareness (lack of sufficient autonomic symptoms when plasma glucose is below 54 mg/dL \[3 mmol/L\]) or other clinically diagnosed neuropathy caused by type 1 diabetes, including but not limited to gastrointestinal autonomic neuropathy Metabolic instability: two or more previous severe hypoglycemic events that required assistance from others, or two or more hospitalizations for ketoacidosis in the past year
* Age ≤ 60 years
* Body weight ≥ 40 kg
* At least one positive islet autoantibody, including glutamic acid decarboxylase autoantibody (GADA), protein tyrosine phosphatase autoantibody (IA-2A), insulin autoantibody (IAA) (only applicable within 2 weeks of insulin treatment), zinc transporter 8 antibody (ZnT8), islet cell autoantibody (ICA), etc.
* MMTT stimulated C-peptide peak \> 0.1 nmol/L, or fasting C-peptide \> 0.05 nmol/L
* Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening
* Both male and female subjects must be willing to use contraception from the time of signing the informed consent form until 12 months after cell infusion
* The subject or their legal guardian voluntarily participates in this study and is able to sign the informed consent form
Exclusion Criteria:
* If any of the following criteria are met, the subject will be excluded from the study.
Type 2 diabetes, or diabetes mellitus from pregnancy, single-gene mutation, pancreatic injury, or other secondary causes (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN, or total bilirubin ≥ 1.5 x ULN
* Severe heart disease, with any of the following:
* Myocardial infarction within 1 year before enrollment
* Signs or symptoms of heart failure of NYHA Class ≥ 3 within 1 year before enrollment
* Left ventricular ejection fraction (LVEF) \< 50% at screening
* QTcF \> 450 msec (males) or \> 470 msec (females), based on the QTcF value from a single ECG or the average of three repeated ECGs taken more than 3 minutes apart (QT interval corrected by Fridericia's formula)
* Severe concurrent diabetic nephropathy, with an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
* Currently undergoing or expected to require renal replacement therapy during the study
* At screening, a subject tests positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e-antigen (HBeAg); a subject tests positive for hepatitis B e-antibody (HBeAb) with a peripheral blood HBV DNA level above the upper limit of normal; a subject tests positive for hepatitis C virus (HCV) antibody; a subject tests positive for human immunodeficiency virus (HIV) antibody; a subject tests positive for syphilis antibody; a subject tests positive for EBER or has an EBV viral load greater than the upper limit of normal
* Participated in another clinical study within 3 months prior to enrollment
* Received a live attenuated vaccine within 4 weeks prior to enrollment
* The investigator considers the patient to have latent T1DM, including latent autoimmune diabetes in adults (LADA) and latent autoimmune diabetes in the young (LADY)
* The investigator believes there are other reasons that make the subject unsuitable for this clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
60 Years
Study:
NCT07142161
Study Brief:
Protocol Section:
NCT07142161