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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00672204
Eligibility Criteria:
Inclusion Criteria:
1. Primary islet allotransplant
2. Type I diabetes mellitus for a minimum of 5 years
3. One of the following signs or symptoms despite intensive efforts made in close cooperation with their diabetic care team:
* Metabolic lability/instability characterized by hypoglycemia or ketoacidosis (\>2 hospital admissions in the previous year), erratic glucose profiles (MAGE\>120 mg/dL), or disruption in lifestyle of danger to life, self or others
* Reduced awareness of hypoglycemia or \>1 episode in the last 1.5 years of severe hypoglycemia
* Persistently poor glucose control (as defined by HgbA1c\>10% at the end of six months of intensive management efforts with the diabetes care team)
* Progressive secondary complications as defined by (i) a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or (ii) urinary albumin excretion rate \>300 mg/day but proteinuria \<3g/day; or (iii) symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist)
4. Age 18 to 65 years of age.
Exclusion Criteria:
1. Current use of immunosuppressive agents
2. Lymphopenia (\<1000/µL) or leukopenia (\<3000 total leukocytes/µL)
3. Presence of panel-reactive anti-HLA antibody \>20%
4. Positive lymphocytotoxic cross-match using donor lymphocytes and serum
5. Evidence of acute EBV infection (IgM\>IgG) OR negative screen for EBV by IgG determination
6. Calculated or measured GFR \< 60 ml/min/m2
7. Portal hypertension or history of significant liver disease
8. History of malignancy within 10 years (except for adequately treated basal or squamous cell CA of the skin)
9. Active peptic ulcer disease
10. Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications
11. Untreated proliferative retinopathy
12. Pregnancy or breastfeeding
13. Female subjects not post-menopausal or surgically sterile, or not using an acceptable method of contraception
14. Active infections
15. Serologic evidence of infection with HIV, or HbsAg or HCV Ab positive
16. Major ongoing psychiatric illness
17. Ongoing substance abuse, drug or alcohol; or recent history of noncompliance
18. Any condition that in the opinion of the Principle Investigator would not allow for safe participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00672204
Study Brief:
Protocol Section:
NCT00672204