The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Location status: Recruiting
NCT Number: NCT06708780
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.
Interested in participating?
Request Info8 year–65 year
All sexes
Interventional
Phase 1
Nanjing, Jiangsu, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 is provided to all participants according to clinical guidelines for T1DM.
Time frame: From enrollment to the end of treatment at 1 year
Time frame: From enrollment to the end of treatment at 1 year
Therapeutic effects on diabetes-related outcomes 1 year after intervention include: 1) C-peptide response during mixed meal tolerance test, reported as the change from baseline in the fasting level, postprandial level and area under the curve; 2) Insulin Use; 3) Hemoglobin A1c.
Interested in participating?
Request InfoThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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