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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT00790257
Eligibility Criteria:
Inclusion Criteria:
* Phase 1A:
1. Male or female patients, of 30 to 80 years of age, C-peptide-negative;
2. Patient must have signed the Patient Informed Consent Form;
3. Type 1 diabetic (T1DM) patients insulin-dependent;
4. T1DM patients already transplanted with a kidney graft and already on immunosuppressive therapy;
5. T1DM patients already transplanted with a vascularized pancreas, already on immunosuppressive therapy, but with TOTAL dysfunction of the graft;
6. T1DM patients already transplanted with a liver graft and already on immunosuppressive therapy;
7. T1DM patients already transplanted with a heart or lung graft and already on immunosuppressive therapy;
8. T1DM patients eligible for simultaneous transplantation with kidney and encapsulated human islets;
9. Donor-Recipient ABO blood group compatibility;
10. Donor- Recipient HLA compatibility.
* Phase 1B:
1. Male or female patients, of 30 to 80 years of age, C-peptide-negative;
2. Patient must have signed the Patient Informed Consent Form;
3. T1DM patients without any immunosuppression who cannot be transplanted with vascularized pancreas (vascular complication, psychological reasons,...). The main objective is to restore a residual insulin secretion to stabilize the diabetes (reduction of hypoglycaemia,…);
4. Donor-Recipient ABO blood group compatibility;
5. Donor- Recipient HLA compatibility.
Exclusion Criteria:
* RECIPIENT EXCLUSION CRITERIA FOR PHASE 1A/B:
1. Patient is pregnant or breastfeeding.
2. Patient has a positive T-cell crossmatch on the most recent serum specimen.
3. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
4. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior inclusion in UCL-HIA-002.
5. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT00790257
Study Brief:
Protocol Section:
NCT00790257