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Clinical Trial Details

Trial ID: L5446
Source ID: NCT01705899
Associated Drug: Human Pancreatic Islets
Title: Islet Allotransplantation in Type 1 Diabetes
Acronym:
Status: SUSPENDED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Human Pancreatic Islets
Outcome Measures: Primary: Incidence of adverse events, Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant|Incidence of serious adverse events, Serious adverse events will be defined (in accordance with FDA Title 21 CFR 312.32) as the following: * Death * Life-threatening and placing the subject at immediate risk of death * Hospitalization * Persistent or significant disability or incapacity * Congenital abnormal/birth defects * Requiring medical or surgical intervention to prevent permanent damage, Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant|Incidence of infectious complications, Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant|Incidence of procedural-related events, Ex. Bleeding or portal vein thrombosis, Day 1 post-transplant|Incidence of elevated liver function tests, Day 1 post-transplant|Incidence of hypoglycemia, Day 1 post-transplant|Incidence of procedural-related events, Ex. Bleeding or portal vein thrombosis, Day 2 post-transplant|Incidence of elevated liver function tests, Day 2 post-transplant|Incidence of hypoglycemia, Day 2 post-transplant|Incidence of procedural-related events, Ex. Bleeding or portal vein thrombosis, Day 3 post-transplant|Incidence of elevated liver function tests, Day 3 post-transplant|Incidence of hypoglycemia, Day 3 post-transplant|Incidence of elevated liver function tests, Day 5 post-transplant|Incidence of hypoglycemia, Day 5 post-transplant|Incidence of elevated liver function tests, Day 7 post-transplant|Incidence of hypoglycemia, Day 7 post-transplant|Incidence of elevated liver function tests, Day 10 post-transplant|Incidence of hypoglycemia, Day 10 post-transplant|Incidence of elevated liver function tests, Day 14 post-transplant|Incidence of hypoglycemia, Day 14 post-transplant|Incidence of elevated liver function tests, Day 21 post-transplant|Incidence of hypoglycemia, Day 21 post-transplant|Incidence of abnormalities in lipids, Day 28 post-transplant|Incidence of elevated liver function tests, Day 28 post-transplant|Incidence of donor-specific antibody development, Day 28 post-transplant|Incidence of hypoglycemia, Day 28 post-transplant|Incidence of elevated liver function tests, Day 42 post-transplant|Incidence of hypoglycemia, Day 42 post-transplant|Incidence of elevated liver function tests, Day 56 post-transplant|Incidence of hypoglycemia, Day 56 post-transplant|Incidence of elevated liver function tests, Day 90 post-transplant|Incidence of hypoglycemia, Day 90 post-transplant|Incidence of abnormalities in lipids, Day 90 post-transplant|Incidence of donor-specific antibody development, Day 90 post-transplant|Incidence of elevated liver function tests, Day 120 post-transplant|Incidence of hypoglycemia, Day 120 post-transplant|Incidence of elevated liver function tests, Day 180 post-transplant|Incidence of hypoglycemia, Day 180 post-transplant|Incidence of abnormalities in lipids, Day 180 post-transplant|Incidence of donor-specific antibody development, Day 180 post-transplant|Incidence of elevated liver function tests, Day 270 post-transplant|Incidence of hypoglycemia, Day 270 post-transplant|Incidence of abnormalities in lipids, Day 270 post-transplant|Incidence of donor-specific antibody development, Day 270 post-transplant|Incidence of elevated liver function tests, Day 365 post-transplant|Incidence of abnormalities in lipids, Day 365 post-transplant|Incidence of hypoglycemia, Day 365 post-transplant|Incidence of donor-specific antibody development, Day 365 post-transplant|Change in microalbumin level, Days 180 and 365 post-transplant|Change in measured creatinine clearance, Days 180 and 365 post-transplant | Secondary: Amount of daily insulin units required, Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant|Measurement of C-peptide, Days 1, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant|Change in c-peptide level from fasting following administration of mixed meal, Patients fasting c-peptide will be measured, then patient will be given a mixed meal of Ensure. The c-peptide level will be checked again at 90 minutes after administration of mixed meal., Days 180 and 365 post-transplant|Change in acute insulin response to glucose, As determined by oral glucose tolerance test and/or intravenous glucose tolerance test, Days 180 and 365 post-transplant|Incidence of blood glucose level <140mg/dl two hours after oral glucose tolerance tests, Days 180 and 365 post-transplant|Change in Quality of Life, Days 180 and 365 post-transplant|Change in hypoglycemia score, Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant|Change in glycemic lability score, Days 1, 2, 3, 5, 7, 10, 14, 21, 28, 42, 56, 90, 120, 180, 270 and 365 days post-transplant
Sponsor/Collaborators: Sponsor: Ohio State University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-11
Completion Date: 2033-10
Results First Posted:
Last Update Posted: 2025-01-16
Locations: The Ohio State University Medical Center, Columbus, Ohio, 43210, United States
URL: https://clinicaltrials.gov/show/NCT01705899