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Clinical Trial Details

Trial ID: L5059
Source ID: NCT03011021
Associated Drug: Liraglutide
Title: Safety and Efficacy of Umbilical Cord Blood Regulatory T Cells Plus Liraglutide on Autoimmune Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type1 Diabetes Mellitus|Autoimmune Diabetes
Interventions: DRUG: Liraglutide|BIOLOGICAL: UCB-Treg|DRUG: Insulin
Outcome Measures: Primary: Adverse effects, Primary outcome measures will be the number of participants with adverse events, laboratory abnormalities and other signs of toxicity. Particular focus will be on the number and severity of infusion reactions, complications related to infection, and any potential negative impact on the course of diabetes., 2 years | Secondary: Change in HbA1C, Measure the HbA1C level after treatment, 2 years|Change in C-peptide, Measure the C-peptide level after treatment, 2 years|Change in insulin dose, Measure insulin dose patient used after treatment, 2 years|Hypoglycaemic events, Measure the number of participants with Hypoglycaemic events, 2 years|Change in titer of autoantibodies, Measure the titer of antoantibodies of participant after treatment, 2 years|Change in immune cells diversities and quantities., Measure the immune cells diversities and quantities after treatment, 2 years|Change in autoimmune-related cytokines, Measure the change of autoimmune- related cytokines after treatment, 2 years|Life quality evaluation, Number of participants with disturbance of emotion, sleep, resting or energy., 2 years
Sponsor/Collaborators: Sponsor: Second Xiangya Hospital of Central South University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-01
Completion Date: 2025-06
Results First Posted:
Last Update Posted: 2023-03-14
Locations: Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, China
URL: https://clinicaltrials.gov/show/NCT03011021