Safety and Efficacy of Umbilical Cord Blood Regulatory T Cells Plus Liraglutide on Autoimmune Diabetes

Sponsor
Second Xiangya Hospital of Central South University
Study ID
NCT03011021
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Autoimmune Diabetes
  • Type1 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Dose escalation of Liraglutide starts from 0.6 mg up to 1.2 mg per day.
  • UCB-Treg — BIOLOGICAL
    Receive Treg infusion: 1\~5\*10\^6/kg b.w. in 100ml normal saline
  • Insulin — DRUG
    Receive insulin following clinician's instruction.

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Mar 2023
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UCB-Treg plus Liraglutide
    Subjects will receive a single infusion of ex vivo expanded umbilical cord blood derived Treg product (2 x 10\^6). Dose escalation of liraglutide up to 1.2 mg will be started 3 days after Treg infusion only if no severe side effects showed. Subjects continue to receive the reached liraglutide dose once daily for 6 months thereafter. Insulin will be continued as a routine therapy.
  • Active Comparator: UCB-Treg
    Subjects will receive a single infusion of ex vivo expanded Treg product (2 x 10\^6). Insulin will be continued as a routine therapy.
  • Active Comparator: Liraglutide
    Patients will be subjected to a dose escalation of liraglutide up to 1.2 mg, then continue to receive the reached liraglutide dose once daily for 6 months thereafter. Insulin will be continued as routine therapy.
  • Active Comparator: Insulin
    Patients will receive insulin injection as a routine therapy.

Primary Outcome Measure

Adverse effects [ Time Frame: 2 years ]

Central Contacts

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