Using umbilical cord blood T cells to treat autoimmune diabetes
Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells on Autoimmune Diabetes
This study is testing whether T cells made from umbilical cord blood can safely help people with autoimmune diabetes manage their condition better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 60 Years |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT02932826 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and therapeutic effects of ex-vivo expanded regulatory T cells derived from umbilical cord blood in patients with autoimmune diabetes. The T cells will be produced from freshly collected umbilical cord blood, sorted, and expanded in a GMP laboratory before being infused into eligible patients. Participants will undergo thorough examinations and monitoring to assess the safety and efficacy of the treatment over time. The study aims to provide a novel cell therapy approach for managing autoimmune diabetes.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 6 to 60 diagnosed with autoimmune diabetes within the last 3 years and who test positive for specific autoantibodies.
Not a fit: Patients with significant liver, kidney, or heart diseases, or those with acute metabolic disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with autoimmune diabetes, potentially improving their disease management.
How similar studies have performed: While the use of regulatory T cells in autoimmune conditions is a growing field, this specific approach using umbilical cord blood T cells is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
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 of Central South University
- 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.