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临床试验/NCT05636839
NCT05636839招募中不适用

UVB-induced Treg Cells Exert Antigen-specific Suppression Through LAG-3

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Change in the percentage of Treg cells

研究概览

简要总结

The goal of this clinical trial is to compare the immune cell population in blood of the participants with psoriasis/atopic dermatitis before and after UVB treatment. The main questions it aims to answer are:

  1. how immune cells in the PBMCs from blood of participants are affected by UVB treatment
  2. will UVB treatment expand the antigen-specific Treg cell population
  3. will UVB treatment enhance the suppressive function of Treg cells

Participants giving written informed consent will donate their blood (20 ml) before UVB treatment begins. After 8 to 10-week treatment course, the participants will donate their blood (20 ml) again.

Researchers will compare immune cell population changes in the PBMCs of participants before and after UVB treatment. In addition, researchers will purify Treg cells from participant blood before and after UVB treatment to test their suppressive activity by ex vivo suppression assay.

详细描述

UVB irradiation suppresses immune responses partly via the induction of Treg cells. However, it is still not clear whether the therapeutic effect of UVB to treat skin inflammatory diseases (such as psoriasis and atopic dermatitis) results from the increase of Treg cell population. In addition, how UVB induces antigen-specific Treg cells needs to be elucidated.

In this study, researchers will examine the Treg cell population in the blood of participants with psoriasis or atopic dermatitis under UVB treatment. We will analyse changes of immune cell populations in the blood of participants using mess cytometry. We will also investigate the suppressive function of Treg cells sorted from peripheral blood mononuclear cells (PBMCs) to see whether UVB treatment will affect the function of Treg cells.

Enrolled participants will donate 20 ml of blood before UVB treatment begins. They will receive UVB irradiation 2 to 3 times per week, and the treatment course will last 8 to 10 weeks, which is defined as a complete treatment. After a complete treatment, the participants will donate 20 ml of blood again, and the trial ends.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 20 years of age
  • Able and willing to provide written informed consent

排除标准

  • UV exposure in the last 8 weeks before study entry
  • Patients with contraindications for UV-treatment
  • History of cancer and primary immunodeficiency
  • pregnant or nursing mother
  • participating in another clinical trial

结局指标

主要结局

Change in the percentage of Treg cells

时间窗: 10 weeks

Change from baseline in Treg cell percentage in the peripheral blood of psoriasis patients treated with UVB

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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