Presence of anemia (Hb ≤100g/L), leukopenia (<3.5×109/L);
Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets
Presence of acute metabolic disorders; In the case of acute ketone acidosis, with
blood ketone over 0.3mmol/L and pH lower than 7.30;
Presence of any kind of chronic infection or immune deficiency, including hepatitis B,
hepatitis C, HIV, syphilis or tuberculosis, etc.;
Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3
Any history of malignancy;
Female patients who are pregnant or breastfeeding; any female who is unwilling to use
a reliable and effective form of contraception for 2 years after recruitment;
Presence of any infectious diseases, including active skin infections, flu, fever,
upper or lower respiratory tract infections; those who wish to participate in the
study should keep the infection under control for at least 1 week before receiving
Treg product infusion;
Any medical condition that, in the opinion of the investigator, will interfere with
safe participation in the trial.
All locations for NCT03011021
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
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Tris trial is registered with FDA with number: NCT03011021. The sponsor of the trial is Second Xiangya hospital of Central South University and it is looking for 40 volunteers for the current phase.
Official trial title: Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells With Liraglutide on Autoimmune Diabetes
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