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

What Was Tested

The trial (phase 1, phase 2) is built around Insulin (regular human) and Liraglutide.

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.

It had four arms (groups): UCB-Treg plus Liraglutide (experimental), UCB-Treg (active comparator), Liraglutide (active comparator) and Insulin (active comparator).

Subjects will receive a single infusion of ex vivo expanded Treg product (2 x 10\^6). Insulin will be continued as a routine therapy.

The registry classes the interventions as biological and drug.

More on the Plan

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).

However, its clinical application in AIDM is not well-defined so far.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 1 diabetes according to ADA criteria \<3 years. Age≥ 18 years. Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A. Written informed consent from the patient or family representative.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: history or family history of medullary thyroid carcinoma or men 2 syndrome;; history of chronic or acute pancreatitis;; allergic to liraglutide or any components in victoza®;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2017-01 with completion listed for 2025-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Adverse effects (time frame: 2 years).

It also tracked 8 secondary outcomes, for example Change in HbA1C, Change in C-peptide, Hypoglycaemic events, Change in titer of autoantibodies, Change in immune cells diversities and quantities and Change in autoimmune-related cytokines.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) and Liraglutide in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Liraglutide compound page, all human trials.