Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
Type 1 Diabetes, Hypoglycemia
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria: Primary islet allotransplant Type 1 diabetes mellitus, complicated by at least one of the following situations that persist despite intensive efforts in close cooperation with their diabetes care team: Metabolic lability/instability; Reduced awareness of 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. Age 18 and older Able to give written informed consent Exclusion Criteria: Known hypersensitivity to rabbit proteins. Presence of history of panel-reactive anti-HLA antibodies (>10%). Insufficient cardiovascular reserve. Creatinine clearance <60 mL/min/m2. Portal hypertension, abnormal liver enzyme tests, or history of significant liver disease. History of malignancy within 5 years. Active peptic ulcer disease. Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications. Pregnancy or breast-feeding. Active infections. Serological evidence of infection with HIV, or HBsAg or HCVAb positive within the previous 12 months prior to transplantation. Negative screen for Epstein-Barr Virus (EBV) by an EBNA method Evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening. Schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medications. Ongoing substance abuse; drug or alcohol. Recent history of noncompliance. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Experimental
1