Immunotherapy with Autologous Tregs in T1DM

Recruiting now · Phase 1

Conditions studied: Type 1 Diabetes Mellitus

In brief

Type 1 diabetes (T1D) is an autoimmune disease characterized by a progressive immune distruction of pancreat beta cells and deterioration of endogenous insulin secretion. Regulatory T cells (Treg) are fuctionally deficient in T1D, leading to the loss of immune tolerance to the islets and the initiation of an autoimmune attack. Previouse studies have revealed the potential theraputic effects of autologous Treg transplantation in T1D. We have modified the preparation protocol for autologous Tregs. The purpose of this study is to assess the safety and effect of autologous Treg therapy in patients with T1D.

Key facts

Study ID

NCT06708780

Run by

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

People needed

20

Starts

2023-04-12

Expected to finish

2027-12-01

Last updated by the study team

2024-11-27

Who can join

Age: 8 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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