Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells on Autoimmune Diabetes

Trial ID: NCT02932826

Interventional - Phase 1/2 - Unknown status

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

• Umbilical Cord Blood Regulatory T cells Therapy
• Insulin

Eligibility

Inclusion criteria

• 1. 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
• 2. Diagnosis of Autoimmune Diabetes within 3 years of screening
• 3. Between 6 to 60 years of age
• 4. Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
• 5. Fasting or postprandial plasma C-peptide more than 200 pmol/L
• 6. Written informed consent from the patient or the patient's parents for patients under the age of 18 years

Exclusion criteria

• 1. Any clinically significant diseases in liver (ALT and AST over 2 times upper normal limit), kidney (Scr over 133umol/L), and heart
• 2. Presence of anemia (Hb ≤100g/L), leukopenia (\<3.5×10\^9/L)
• 3. Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets \<100×10\^9/L)
• 4. 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
• 5. Presence of any kind of chronic infection or immune deficiency, including hepatitis B, hepatitis C, HIV, syphilis or tuberculosis
• 6. Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months
• 7. Any history of malignancy
• 8. Female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years afer recruitment
• 9. Presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory track 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
• 10. Presence of diabetic microvascular or macrovascular diseases
• 11. Presence of hypertension
• 12. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial

Sponsor

Second Xiangya Hospital of Central South University

Source: ClinicalTrials.gov

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