The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells adjunct with Liraglutide on autoimmune diabetes.
Autoimmune Diabetes Mellitus (AIDM) is a subtype of diabetes mellitus caused by autoimmune destruction of beta cells in the islet, including Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA). Insulin has been used as a routine therapy for AIDM to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of beta cells or preserve its function. Regulatory T cells expanded from umbilical cord blood (UCB-Treg) ex-vivo have shown strong capacity to control immune responses in autoimmune diseases, offering a hopeful therapeutic way for AIDM. Glucagon-like peptide (GLP-1) analog Liraglutide has been tested in large-scale clinical trial to prove its various benefits for beta cells and glucolipid metabolism in Type 2 diabetes and obesity patients. However, its clinical application in AIDM is not well-defined so far. The aim of this study is to investigate the potential use of Liraglutide with UCB-Treg infusion in AIDM and examine the safety and efficacy of this new therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Dose escalation of Liraglutide starts from 0.6 mg up to 1.2 mg per day.
Receive Treg infusion: 1\~5\*10\^6/kg b.w. in 100ml normal saline
Receive insulin following clinician's instruction.
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGAdverse 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.
Time frame: 2 years
Change in HbA1C
Measure the HbA1C level after treatment
Time frame: 2 years
Change in C-peptide
Measure the C-peptide level after treatment
Time frame: 2 years
Change in insulin dose
Measure insulin dose patient used after treatment
Time frame: 2 years
Hypoglycaemic events
Measure the number of participants with Hypoglycaemic events
Time frame: 2 years
Change in titer of autoantibodies
Measure the titer of antoantibodies of participant after treatment
Time frame: 2 years
Change in immune cells diversities and quantities.
Measure the immune cells diversities and quantities after treatment
Time frame: 2 years
Change in autoimmune-related cytokines
Measure the change of autoimmune- related cytokines after treatment
Time frame: 2 years
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Life quality evaluation
Number of participants with disturbance of emotion, sleep, resting or energy.
Time frame: 2 years