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:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT02505893
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent
* Mentally stable and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
* New-onset T1D (diagnosis of diabetes within 180 days prior to enrolment). Documentation of the diagnosis of T1DM (and not just insulin deficiency), including the date of diagnosis, must be obtained from the diagnosing physician.
* Residual beta-cell function (fasting C-peptide \>0.3 ng/mLwhen plasma glucose level is \> 70 mg/dL and ≤ 200 mg/dL.
* Positive for at least one of the following autoantibodies typically associated with T1DM: antibody to glutamic acid decarboxylase (anti-GAD) antibody to protein tyrosine phosphatase-like protein (anti-IA-2), zinc transporter autoantibodies; or an insulin autoantibody (IAA). Please note: A subject who is positive for IAA and negative for the other autoantibodies will not be eligible if the subject has been using insulin for a total of ≥7 days.
* Currently requires insulin for T1DM treatment, or has required insulin therapy (for at least 7 days) for diabetes at some time between the date of diagnosis and the first dose of study drug. Note: subjects currently taking twice daily commercially available pre-mixed insulin will not be eligible.
* MinimalHLA I A and B mismatch and at least one HLA DR match
Exclusion Criteria:
* Body mass index (BMI) ≥ 32.0 kg/m2 or patient weight ≤50kg
* Insulin requirement of \>1.0 IU/kg/day
* HbA1c \>10%
* Blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg.
* Chronic disease apart from diabetes, including type 2 diabetes
* Moderate to severe renal impairment as per calculated creatinine clearance (CLcr) \< 90 mL/min according to the Cockcroft-Gault formula (Cockcroft-Gault , 1976)
* Presence or history of macroalbuminuria (\>300mg/g creatinine).
* Hepatic dysfunction defined by increased ALT/AST upper limit of normal (ULN) and increased total bilirubin \> 3 mg/dL \[\>51.3 μmol/L\]
* Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 4 months after the end of study drug administration (females and males)
* Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB) as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. Positive tests are otherwise not acceptable, even in the absence of any active infection at the time of evaluation.
* Negative screen for Epstein-Barr Virus (EBV) by IgG determination
* Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within one year prior to study enrollment
* Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
* Known active alcohol or substance abuse
* Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (\<1,000/µL), neutropenia (\<1,500/µL), or thrombocytopenia (platelets \<100,000/µL). Participants with lymphopenia are allowed if the investigator determines there is no additional risk and obtains clearance from a hematologist
* A history of Factor V deficiency
* Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or patients with an international normalized ratio (INR) \>1.5
* Severe co-existing cardiac disease, characterized by any one of these conditions:
* a) recent myocardial infarction (within past 6 months)
* b) evidence of ischemia on functional cardiac exam within the last year
* c) left ventricular ejection fraction \<30%.
* Symptomatic cholecystolithiasis.
* Acute or chronic pancreatitis.
* Symptomatic peptic ulcer disease.
* Severe unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications
* Hyperlipidemia despite medical therapy (fasting low-density lipoprotein \[LDL\] cholesterol \>130 mg/dL, treated or untreated; and/or fasting triglycerides \>200 mg/dL)
* Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of ≥ 5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only.
* Treatment with any anti-diabetic medication other than insulin within 4 weeks of enrollment
* Use of any investigational agents within 4 weeks of enrollment.
* Administration of live attenuated vaccine(s) within 2 months of enrollment.
* Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
* Treatment with any immunosuppressive regimen at the time of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02505893
Study Brief:
Protocol Section:
NCT02505893