Safety Study and Therapeutic Effects of Umbilical Cord Blood Treg on Autoimmune Diabetes

What Was Tested

This registered phase 1, phase 2 trial tested Insulin (regular human).

The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells on autoimmune diabetes.

It had two arms (groups): Treg Treatment + Insulin (experimental) and Insulin (active comparator).

Subjects will be treated with Umbilical Cord Blood Regulatory T cells Therapy and insulin according to routine clinical practice at the discretion of the treating physician.

Subjects will be treated with insulin according to routine clinical practice at the discretion of the treating physician.

The registry classes the interventions as biological and drug.

More on the Plan

The regulatory T cells (Treg) used in this study will be produced from human umbilical cord blood.

The umbilical cord blood will be freshly collected and immediately separated to buffy coat in a GMP laboratory, thus to be further sorted into Treg and other subsets.

Then the Treg will be expanded ex-vivo for approximately 14 days until tested for its surface markers and suppressive ability.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 6 years up to 60 years.

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

Examples of who could join: Autoimmune diabetes patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association. Diagnosis of Autoimmune Diabetes within 3 years of screening. Between 6 to 60 years of age. Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A. Written informed consent from the patient or the patient's parents for patients under the age of 18 years.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets \<100×10\^9/l); presence of any kind of chronic infection or immune deficiency, including hepatitis b, hepatitis c, hiv, syphilis or tuberculosis; chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-10 with completion listed for 2025-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants with Adverse events as a Measure of Safety and Tolerability (time frame: 2 years).

It also tracked 5 secondary outcomes, for example C-peptide, Insulin requirement, Blood glucose, HbA1c and Autoimmune Status.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) 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, all human trials.