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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKoç University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Multiple Sclerosis

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: People with MS
Group B: Health Control

Trial outcomes

Primary outcomes

1

VISTA Protein Secretion

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

Time frame
Baseline, Week 0

Secondary outcomes

1

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

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.

Time frame
Baseline, Week 0
2

Clinical and Radiological Correlation

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

Time frame
Baseline, Month 6, Month 12

Other outcomes

Sponsors and contacts

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