Treatment of Patients With Systemic Sclerosis With Autologous Regulatory Т-cells
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ACR/EULAR systemic sclerosis criteria
研究概览
简要总结
Treatment of patients with systemic sclerosis with autologous regulatory Т-cells
详细描述
Considering the fact that a decrease in the content and functional activity of T-reg plays an important role in the immunopathogenesis of many systemic diseases of the connective tissue, the use of a large amount of T-reg can have a therapeutic effect.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Systemic Sclerosis
- •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 systemic sclerosis receiving standard treatment and autologous regulatory Т-cells
Group 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells
干预措施: Standard treatment according to the clinical protocols (Other)
Patients with multiple sclerosis receiving standard treatment
Group 2: Patients with multiple sclerosis receiving standard treatment
干预措施: Standard treatment according to the clinical protocols (Other)
Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells
Group 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells
干预措施: Autologous Regulatory Т-cells (Biological)
结局指标
主要结局
ACR/EULAR systemic sclerosis criteria
时间窗: 1 year
Сalculation of ACR/EULAR systemic sclerosis criteria score
Adverse effects associated with the therapy
时间窗: 1 year
Determination of adverse effects associated with the therapy
ACR/EULAR systemic sclerosis criteria
时间窗: 6 month
Сalculation of ACR/EULAR systemic sclerosis criteria score
Adverse effects associated with the therapy
时间窗: 1 month
Determination of adverse effects associated with the therapy
次要结局
未报告次要终点