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临床试验/NCT06957145
NCT06957145已完成不适用

Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation: A 1-Year Follow-up Study

Koç University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
VISTA Protein Secretion

研究概览

简要总结

The aim of this study is to investigate whether VISTA, a newly identified negative immune regulatory protein, differs in monocytes and T cells of patients diagnosed with Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS) compared to the same cell types in healthy controls. Additionally, the potential clinical correlation of VISTA expression in the follow-up of MS and CIS patients will be examined. By elucidating the role of VISTA in the pathophysiology of MS, this study will contribute to the literature by exploring its potential as a biomarker and its relevance in the development of novel therapeutic strategies.

Specifically, this study will compare VISTA protein secretion in MS patients at the time of their first attack with that of healthy controls. Furthermore, changes in VISTA protein secretion will be assessed in blood samples collected at 6- and 12-month follow-ups, and the correlations of these changes with clinical and laboratory findings will be investigated.

Finally, this study aims to determine whether CD4+ and CD8+ T cells, monocytes, and T regulatory (Treg) subgroups in the first attack blood samples of MS patients exhibit similar functional properties in terms of VISTA protein secretion as their counterparts in healthy controls. To achieve this, monocytes and T cell subtypes will be stimulated, and their pro- and anti-inflammatory cytokine responses will be analyzed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • •Patients aged 18 years or older diagnosed with MS or CIS according to the 2017 McDonald criteria.
  • •No diagnosis of any autoimmune disease or malignancy.
  • •No new diagnosis of autoimmune disease or malignancy during the 1-year follow-up period.
  • •No use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroid treatments within one month prior to blood sampling.
  • •No vaccination within one month prior to blood sampling.
  • •Not in the menstrual cycle at the time of blood sampling.

排除标准

  • •Age below 18 years.
  • •Presence of a previous or newly diagnosed autoimmune disease or malignancy at the time of blood sampling.
  • •Use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroid treatments within one month prior to blood sampling.
  • •Vaccination within one month prior to blood sampling
  • •Being in the menstrual cycle at the time of blood sampling
  • •Patients without a definitive MS diagnosis according to the 2017 McDonald criteria will not be included in the study.

研究组 & 干预措施

People with MS

30 People with MS

Health Control

30 Health Control

结局指标

主要结局

VISTA Protein Secretion

时间窗: Baseline, Week 0

Comparison of VISTA protein secretion levels in blood samples of MS patients at the time of their first attack with those of healthy controls.

次要结局

  • Functional Comparison of Immune Cell Subsets via Cytokine Profiling and VISTA Expression Analysis(Baseline, Week 0)
  • Clinical and Radiological Correlation(Baseline, Month 6, Month 12)

研究者

发起方
Koç University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rabia Gökcen Gozubatik Celik

Assoc. Prof.

Koç University

研究点 (2)

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