Using patients' own T cells to treat Type 1 Diabetes
Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM
This study is testing whether using patients' own T cells can help treat Type 1 Diabetes by restoring the immune system's ability to protect insulin-producing cells.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 8 Years to 65 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06708780 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of autologous regulatory T cell therapy in patients with Type 1 Diabetes Mellitus (T1DM). The study aims to address the immune dysfunction associated with T1DM by utilizing ex vivo expanded human autologous Tregs, which are designed to restore immune tolerance to pancreatic beta cells. Participants will undergo a modified preparation protocol for Tregs, and their responses will be monitored throughout the trial. The study is conducted at The Affiliated Nanjing Drum Tower Hospital, focusing on a specific patient population aged 8 to 65 years.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 8 to 65 years diagnosed with Type 1 Diabetes and showing specific autoimmune markers.
Not a fit: Patients with uncontrolled diabetic ketoacidosis, severe allergies, or other significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could help restore insulin production and improve blood sugar control in patients with Type 1 Diabetes.
How similar studies have performed: Previous studies have indicated potential therapeutic effects of autologous Treg transplantation in Type 1 Diabetes, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes; * Aged 8 to 65 years; * At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L; * Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study. Exclusion Criteria: * The condition of diabetic ketoacidosis has not been controlled; * Severe allergic constitution; * Known or suspected tumor; * Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases. * Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.); * Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding. * Mental illness, alcohol or drug abuse, unable to cooperate with treatment; * According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.
Where this trial is running
Nanjing, Jiangsu
- The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Dr. Lu, MD
- Email: lujing@njglyy.com
- Phone: 0086-025-868182432
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.