NCT06708780

Immunotherapy with Autologous Tregs in T1DM

Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 8 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-12
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-11-27
• Last updated: 2024-11-27

Locations

1 site across 1 country: China