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RECRUITING
NCT06708780
PHASE1

Immunotherapy with Autologous Tregs in T1DM

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

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.

Official title: Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM

Key Details

Gender

All

Age Range

8 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-04-12

Completion Date

2027-12

Last Updated

2024-11-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

Ex 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.

OTHER

Routine 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