Safety and Efficacy of Umbilical Cord Blood Regulatory T Cells Plus Liraglutide on Autoimmune Diabetes
NCT03011021 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-03-14
Summary
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.
Conditions
- Type1 Diabetes Mellitus
- Autoimmune Diabetes
Interventions
- DRUG
-
Dose escalation of Liraglutide starts from 0.6 mg up to 1.2 mg per day.
- BIOLOGICAL
-
UCB-Treg
Receive Treg infusion: 1\~5\*10\^6/kg b.w. in 100ml normal saline
- DRUG
-
Receive insulin following clinician's instruction.
Sponsors & Collaborators
-
Second Xiangya Hospital of Central South University
lead OTHER
Principal Investigators
-
Zhiguang Zhou, MD/PhD · Second Xiangya Hospital
-
Haibo Yu, MD/PhD · Second Xiangya Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-31
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
Countries
- China
Study Locations
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