Identification of Adaptive and Trained Immune Mechanisms Driving Tissue Fibrosis in IgG4-Related Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures
研究概览
简要总结
Enquire involvement of trained immunity in the pathogenesis of IgG4RD
详细描述
Enquire involvement of trained immunity in the pathogenesis of IgG4RD using primary macrophages and co-cultures with patient derived fibroblasts. The investigators will first assess whether macrophages from patients are trained compared to macrophages of healthy controls and then challenge them with IgG from IgG4RD patients to evaluate the functional effects on cultivated fibroblasts.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects > or = 18 years of age
- •Subjects capable of providing informed consent
- •Active IgG4-RD based on the IgG4-related disease activity index
- •Fulfillment of the 2019 ACR/EULAR Classification Criteria for IgG4RD
- •Healthy Controls:
- •Adult subjects > or = 18 years of age
- •Subjects capable of providing informed consent
排除标准
- •Patients and healthy controls:
- •Subjects < 18 years of age
- •Pregnant women
- •Comorbidities (other ongoing active autoimmune diseases, ongoing cancer, ongoing infections)
- •Ongoing immunosuppressive therapy
结局指标
主要结局
Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures
时间窗: 7 months
Concentration of collagen Ia (ng/uL) in the supernant of macrophage/fibroblast co-cultures through ELISA assay
次要结局
未报告次要终点
研究者
Emanuel Della Torre
Principal Investigator, Assistant Professor of Internal Medicine
IRCCS San Raffaele