Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes;
- •Aged 8 to 65 years;
- •At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L;
- •Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.
排除标准
- •The condition of diabetic ketoacidosis has not been controlled;
- •Severe allergic constitution;
- •Known or suspected tumor;
- •Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases.
- •Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
- •Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
- •Mental illness, alcohol or drug abuse, unable to cooperate with treatment;
- •According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.
研究组 & 干预措施
Treg Group
Participants in this group are transplanted with expanded autologous Tregs in addition to routine therapy for T1DM.
干预措施: Ex vivo Expanded Human Autologous Regulatory T Cells (Biological)
Treg Group
Participants in this group are transplanted with expanded autologous Tregs in addition to routine therapy for T1DM.
干预措施: Routine Care (Other)
Control Group
Participants in this group receive only routine therapy for T1DM.
干预措施: Routine Care (Other)
结局指标
主要结局
Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity.
时间窗: From enrollment to the end of treatment at 1 year
次要结局
- Therapeutic effects on diabetes-related outcomes(From enrollment to the end of treatment at 1 year)
研究者
Zhu DaLong
Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School