Overview

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.