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Clinical Trial Details

Trial ID: L6893
Source ID: NCT00006505
Associated Drug: Islet Transplantation
Title: Solitary Islet Transplantation for Type 1 Diabetes Mellitus Using Steroid Sparing Immunosuppression
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 1
Interventions: DRUG: Islet Transplantation
Outcome Measures: Primary: Insulin independence, To reproduce and improve upon a pilot series of clinical islet transplants from Edmonton, using steroid free immunosuppression in conjunction with defined isolation, characterization and transplantation protocols. The study will determine the number of patients receiving an islet allotransplant who are insulin independent at 1 year post-transplant of at least 10,000 IEQ/kg body weight., every three months | Secondary: Islet cell survival, Estimating islet cell survival post transplantation by evaluating the following criteria: Arginine stimulated C- peptide response, Insulin dose expressed as units/kilogram recipient body weight, Incidence of severe hypoglycemia, Monthly monitoring of hemoglobin A1c concentrations for 12 months post transplant completion, and annually for two years thereafter., every 3 months|Immune mediated beta cell destruction, These studies will include:A. Autoimmune markers (ICA512, anti-GAD, and anti- insulin)B. Autoantibody isotypesC. Lymphocytotoxic antibody screen (pre-transplant, between the two islet infusions, and 3, 6 and 12 months post last transplant)D. Retrospective lymphocytotoxic crossmatchE. Other- cells and serum will be frozen pre and 3, 6, and 12 months post transplant for assays being developed, every 3 months|Glomerular filtration rate, To determine whether the islet transplant procedure has had any effect on renal function. Glomerular filtration rate will be assessed as part of the screening procedure, and at 6 months, 1 year, and 3 years following he initial islet transplant, every 3 months|change in lipid profiles, To determine whether the immunosuppressive regimen influences lipid profiles, a fasting lipid panel will be drawn monthly for 12 months post transplant, and antihyperlipidemic therapy will be monitored., every 3 months
Sponsor/Collaborators: Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 6
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2000-11-16
Completion Date: 2020-04-21
Results First Posted:
Last Update Posted: 2021-04-20
Locations: National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
URL: https://clinicaltrials.gov/show/NCT00006505