Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation

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.

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Key information

Conditions

Multiple Sclerosis, MS Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Koc University, Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

VISTA Protein Secretion

Time frame: 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.

Secondary outcomes

Functional Comparison of Immune Cell Subsets via Cytokine Profiling and VISTA Expression Analysis

Time frame: Baseline, Week 0

VISTA protein expression levels in CD4+ and CD8+ T cells, monocytes, and regulatory T (Treg) cell subgroups from first attack blood samples of pwMS and healthy controls, measured by flow cytometry. VISTA protein secretion levels in the same cell subgroups, measured by multiplex cytokine assays. Cytokine responses (pro- and anti-inflammatory) in stimulated monocytes and T cell subsets, measured by flow cytometry and multiplex cytokine assays.
Clinical and Radiological Correlation

Time frame: Baseline, Month 6, Month 12

Demographic data, routine neurological examination findings, EDSS scores, cerebrospinal fluid (CSF) results, and MRI findings collected during the 1-year follow-up. Visual Evoked Potential (VEP) measurements during the same period. VISTA protein secretion levels and temporal changes measured by multiplex cytokine assays

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 4, 2025
Registry last updated: Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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