RecruitingPhase 1NCT06708780

Immunotherapy with Autologous Tregs in T1DM

Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

20 participants

Start Date

Apr 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 8 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether infusing a patient's own regulatory immune cells (called Tregs, expanded in the lab) can help preserve the insulin-producing cells remaining in the pancreas and reduce the need for insulin injections in people with Type 1 diabetes. **You may be eligible if...** - You have been diagnosed with Type 1 diabetes per current Chinese guidelines - You are between 8 and 65 years old - You have at least one positive diabetes-related autoantibody and/or limited remaining insulin production - You can provide written consent and comply with study requirements **You may NOT be eligible if...** - You are currently experiencing uncontrolled diabetic ketoacidosis - You have a known or suspected tumor or severe allergies - You have severe heart, liver, kidney, rheumatic, respiratory, nervous system, or infectious disease - Your diabetes is caused by something other than autoimmune destruction (e.g., gestational diabetes, genetic mutation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALEx vivo Expanded Human Autologous Regulatory T Cells

Peripheral blood component donation is used to collect Treg cells for ex vivo expansion, with technical guidance provided by the Center for Biotechnology Drug Development at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.

OTHERRoutine Care

Routine care is provided to all participants according to clinical guidelines for T1DM.


Locations(1)

The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06708780


Related Trials