Islet Cell Transplantation Alone in Patients With Type I Diabetes Mellitus: Steroid-free Immunosuppression
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type I Diabetes Mellitus, Immunosuppression, Islet Cell Transplantation, PercutaneousTranshepaticPortalVein Catheterization
Eligibility Criteria
Inclusion Criteria: Candidates must be between the ages of 18 and 65 Candidates must have had IDDM for at least 5 years and been under physician care for at least 6 months prior to enrollment in trial. Eligible candidates will have poorly controlled insulin-dependent diabetes mellitus (IDDM) and manifest signs and symptoms severe enough to be incapacitating. These symptoms can include episodes of hypoglycemic unawareness (failure to recognize blood glucose levels < 54 mg/dl) or episodes requiring the assistance of others. Candidates may have poor diabetes control despite intensive insulin therapy (HbA1c > 8.0%). Creatinine clearance should be > 60 ml/min) Body Mass Index should be less than 26 Women of child-bearing age must have a negative pregnancy test and agree to follow effective contraceptive measures for the duration of the trial. Exclusion Criteria: Previous or concurrent organ transplant Previous or concurrent malignancy Untreated proliferative diabetic retinopathy Unstable cardiovascular status, including positive stress echocardiography (if > age 35) Active infections, including x-ray evidence of pulmonary infection Peptic ulcer disease, gall stones, or portal hypertension Abnormal liver function tests Presence of panel reactive antibodies > 20% Creatinine clearance < 60 ml/min HbA1c 12% Serological evidence of HIV, HbsAg, or HCV Anemia (hemoglobin < 12.0) Any condition or circumstance, including psychogenic factors, that preclude therapeutic compliance or otherwise make it unsafe to undergo an islet cell transplant. PSA > 4 in males
Sites / Locations
- University of Miami Diabetes Research Institute