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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Xiangya Hospital of Central South University
• Treatments: Insulin; Insulin, Globin Zinc; Liraglutide

Criteria

Inclusion Criteria:

• 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

• Fasting or postprandial plasma C-peptide more than 100 pmol/L

• Written informed consent from the patient or family representative.

Exclusion Criteria:

• 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®;

• Hepatic abnormalities (transaminase > 2 times normal);

• Renal impairments (serum creatinine >133 umol/L);

• Cardiovascular diseases (hypertension, coronary heart disease, etc.);

• Presence of anemia (Hb ≤100g/L), leukopenia (<3.5×109/L);

• Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets <100×109/L);

• 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 months;

• 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.