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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT01947569
Eligibility Criteria:
Inclusion Criteria:(both open label phase IB safety and Phase IIA study):
1. Patients with new onset T1DM (\>18 years of age for the phase IB and then \>16 (first 10 subjects), \>12 years of age for the second 10 subjects, \> 8 years for the next 10 subjects and, finally, \>8 years of age for the remainder of the phase IIA patients) within 6 months of diabetes mellitus diagnosis.
2. Evidence of decreased β-cell function as measured by C-peptide and blood glucose levels consistent with impaired glucose tolerance.
3. Evidence of at least one high-risk HLA haplotype.
4. Evidence of at least one diabetes-related autoantibody (e.g. IA-2, GAD, ZnT8) ,
5. Adequate immune competence as assessed by immunoreactivity to alloantigens in mixed leukocyte culture and reactivity to viral antigens (CEF Pool Assay) in vitro.
6. Normal hematologic, liver and kidney function.
7. Female participants of childbearing potential in this study must agree to use an effective form of birth control during study participation. Reliable and effective forms of birth control include: true abstinence, intrauterine device (IUD), hormonal-based contraception, double-barrier contraception \[condom or occlusive cap (diaphragm or cervical cap) with spermicide\], or surgical sterilization (vasectomy for male partner, tubal ligation or hysterectomy). Sexually active male participants must agree to use an effective form of birth control such as condoms.
Exclusion Criteria:(both open label phase IB safety and Phase IIA study):
1. Enrollment or history of enrollment in a drug, or biologic therapy study sponsored by TrialNet.
2. A significant history or current evidence of cardiac disease, uncontrolled hypertension, serious arrhythmias.
3. Evidence of active infection requiring antibiotic therapy.
4. History of other concurrent significant medical diseases.
5. Pregnant or lactating women.
6. Patients requiring chronic systemic corticosteroids.
7. Any other immune disorder including but not limited to other autoimmune diseases, HIV, HBV, HCV, HPV, HSV positivity.
8. Impaired renal function with a creatinine level \> 1.5.
9. Administration of the following therapies while patients are undergoing treatment on this protocol: i) radiation therapy; ii) chemotherapy; iii) corticosteroids (except when administered in life-threatening circumstances); iv) other particle or cell-based therapies; v) other biologic therapies; vi) other therapies aimed at modulating the immune system; vii) other endocrine-related therapies, hormone replacement (other than thyroxine and contraceptive), glucoregulation.
10. A hemaglobinopathy known to interfere with the ability to accurately determine HbA1c.
11. No prior radiation therapy, immunotherapy, or chemotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
35 Years
Study:
NCT01947569
Study Brief:
Protocol Section:
NCT01947569