Immunotherapy with Autologous Tregs in T1DM

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for Type 1 Diabetes Mellitus (T1DM) using a type of immune cell called regulatory T cells (Tregs) that come from the patients themselves. In T1DM, the body mistakenly attacks its own insulin-producing cells, leading to high blood sugar levels. The goal of the study is to see if giving patients their own modified Tregs can help improve their immune system's response and potentially slow down the progression of the disease.

To be eligible for this trial, participants must be between 8 and 65 years old, have a confirmed diagnosis of T1DM, and show certain signs of the disease, like having specific antibodies in their blood. They should also be able to provide consent to participate. The study is currently recruiting participants, and those who join can expect to receive personalized care and closely monitored treatment as researchers gather important safety and effectiveness information. It’s important for potential participants to know that certain health conditions, pregnancy, or recent serious illnesses may exclude them from joining the trial to ensure their safety.

Gender

ALL

Eligibility 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.