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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT06938334
Eligibility Criteria:
Inclusion Criteria:
1. Capable of giving signed informed consent, compliance with the requirements and restrictions listed in the Informed Consent Form and the protocol.
2. Male and or female patients.
3. Age ≥18 and ≤40 years
4. Patient able to comply with all protocol procedures for the duration of the study.
5. Recent T1D onset/diagnosis (patients should receive the DP within 180 days from the 1st insulin administration).
6. HbA1c ≥53 and ≤150 mmol/mol
7. Positivity to at least 2 autoantibodies (i.e., anti-insulin, IAA; anti-glutamic acid decarboxylase 65, GAD65; anti-islet antigen 2, IA-2A; anti-zinc transporter 8, ZnT8; anti-islet cell antibody, ICA).
8. Basal C-peptide levels ≥0.2 nmol/L or ≥0.6 ng/mL; if basal C-peptide levels \<0.2 nmol/L, stimulated C-peptide peak ≥0.2 nmol/L or ≥0.6 ng/mL during a 2-hour MMTT; MMTT should not be performed within one week of resolution of a diabetic ketoacidosis event.
Exclusion Criteria:
1. Unwillingness to sign the informed consent.
2. Type 2 diabetes
3. Any other unstable chronic disease
4. Significant systemic infection during the four weeks before requiring hospitalisation, administration of intravenous antibiotics, surgery
5. Present administration of chemotherapeutic anti-neoplastic drugs.
6. QTcF \>470 msec.
7. Occurrence of an episode of ketoacidosis or hypoglycaemic coma in the past two weeks.
8. Presence of a ≥grade 3 adverse event (including laboratory analyses) according to CTCAE version 5.0.
9. Evidence of clinically significant abnormalities at bone-marrow aspirate
10. Body Mass Index (body weight\*height2 )\>27 kg⁄m2
11. A positive result to Biological Screening testing for Anti-HCV Antibody (Ab), HCV nucleic acid test (NAT) (if anti-HCV Ab positive), HIV-1/-2 p24 Ab and antigen (Ag), HIV RNA NAT, anti-Treponema pallidum total Ig, HbsAg (Australia Ag), HBV DNA NAT, total anti-HB core Ab (if HBV DNA NAT positive), anti-HTLV I, and anti-HTLV II (if applicable).
12. Active SARS-CoV-2 infection.
13. Allergy to mobilizing agents (G-CSF and plerixafor).
14. Pregnancy or lactation
15. Absence of an efficacious method of contraception
16. Any condition that in the opinion of investigator contraindicate apheresis or infusion of transduced HSPCs or affects patient's compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06938334
Study Brief:
Protocol Section:
NCT06938334