A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Autoantigen specific T cell count
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of the administration of tolerogenic dendritic cells in patients with type 1 diabetes mellitus.
详细描述
The purpose of this study is to determine the safety and tolerability of the administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides in patients with type 1 diabetes mellitus.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type 1 Diabetes Mellitus
- •The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- •Written informed consent
排除标准
- •The presence of any malignant tumor within the last 5 years
- •Acute or chronic diseases in the stage of decompensation
- •Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
- •Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
- •Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
- •Patients are unable or unwilling to give written informed consent and / or follow research procedures
- •Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
研究组 & 干预措施
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
干预措施: Autologous tolerogenic dendritic cells (Biological)
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
干预措施: Standard treatment according to the clinical protocols (Other)
Patients with Type 1 Diabetes Mellitus receiving standard treatment
Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment
干预措施: Standard treatment according to the clinical protocols (Other)
结局指标
主要结局
Autoantigen specific T cell count
时间窗: 1 year
To determine the autoantigen specific T cell count using the flow cytometry
Adverse effects associated with the therapy
时间窗: 1 year
Determination of adverse effects associated with the therapy
The glucose concentration in blood
时间窗: 1 year
To assess the glucose concentration in blood
The glycated hemoglobin concentration
时间窗: 1 year
To assess the β-cell function measured by the glycated hemoglobin in blood
The C-peptide level in blood
时间窗: 1 year
To assess the β-cell function measured by the C-peptide level
次要结局
未报告次要终点