Using umbilical cord blood cells and Liraglutide to treat autoimmune diabetes
Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells With Liraglutide on Autoimmune Diabetes
This study is testing if a new treatment combining umbilical cord blood cells and Liraglutide can help adults with Type 1 diabetes better manage their blood sugar and protect their insulin-producing cells.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT03011021 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of ex-vivo expanded umbilical cord blood regulatory T cells combined with Liraglutide for treating autoimmune diabetes, including Type 1 diabetes. The approach aims to control immune responses that damage insulin-producing beta cells, while Liraglutide is known for its benefits in glucose metabolism. Participants will receive both treatments to assess their combined impact on preserving beta cell function and managing blood sugar levels. The study will include adult patients diagnosed with Type 1 diabetes within the last three years and will monitor their response to the therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Type 1 diabetes diagnosed within the last three years and positive for specific anti-islet autoantibodies.
Not a fit: Patients with a history of certain cancers, pancreatitis, severe cardiovascular diseases, or significant renal and hepatic impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help preserve beta cell function and improve blood sugar control in patients with autoimmune diabetes.
How similar studies have performed: While the combination of umbilical cord blood regulatory T cells and Liraglutide is a novel approach, similar therapies targeting immune modulation in autoimmune diseases have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Zhiguang Zhou, MD/PhD — Second Xiangya Hospital
- Study coordinator: Zhiguang Zhou, MD/PhD
- Email: zhouzg@hotmail.com
- Phone: 86-731-85292154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.