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临床试验/NCT02711657
NCT02711657已完成不适用

Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Measure fibrocytes in peripheral blood.

研究概览

简要总结

To study Fibrocytes in patients with Rheumatoid Arthritis, Interstitial lung disease and severe asthma and healthy controls.

详细描述

Objectives: 1) To demonstrate that circulating CD45+ CD34+ CD11b+ cells can express Procollagen 1 and thereby show that these markers can be used to identify circulating fibrocytes. 2) To measure the levels of circulating CD45+, CD34+, CD11b+ cells in patients with RA, Fibrotic ILDs, severe asthma and in healthy controls (HC). 3) To compare the levels with number of peripheral blood mononuclear cells (PBMC) that differentiate to mature fibrocytes in vitro.

Method: The CD45+, CD34+, CD11b+ cells from 4 patients were isolated by cell sorting, and stained for Procollagen. 30 patients (10 of each RA, fibrotic ILDs: IPF or non-specific interstitial pneumonitis (NSIP), severe asthma) and 10 HC were included. Current medication, disease activity, lung function and radiographic data were collected. In 100 µL of lysed blood cells were enumerated by flowcytometry. Further, PBMC were isolated and cultured for 5 days. Coverslips from two wells were stained and mature fibrocytes counted and reported as fibrocytes per 106 PBMC originally added to the well.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 10 patient with rheumatoid arthritis.
  • 10 patient with rheumatoid arthritis and interstitial lung disease
  • 10 patients with interstitial lung disease (idiopathic pulmonary fibrosis or nonspecific interstitial pneumonia)
  • 10 patients with asthma
  • 10 healthy volunteers

排除标准

  • Unable to sign written informed consent to participate in the study.

结局指标

主要结局

Measure fibrocytes in peripheral blood.

时间窗: Baseline

To measure the levels of circulating CD45+, CD34+, CD11b+ cells (cells/uL) in patients with RA, Fibrotic ILDs, severe asthma and in healthy controls (HC).

次要结局

  • Compare circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of fibrocytes in cultured cells (fibrocytes/cultured peripheral blood mononuclear cells).(Baseline)
  • Fibrocytes and lung diffusion capacity.(Baseline)
  • Fibrocytes and rheumatoid arthritis(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Søren Andreas Just

MD, Ph.D. Student

Odense University Hospital

研究点 (2)

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