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Immunotherapy with Autologous Tregs in T1DM
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
Conditions
Interventions
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.
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