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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis, MS

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Bakirkoy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatric, Neurologic and Neurosurgical Diseases, University of Health Sciences, Istanbul, Turkey
    • Contact: Rabia Gokcen Gozubatik Celik; Phone Number: 05549370087; Email: rcelik22@ku.edu.tr
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye)
      • Recruiting
      • Koc University
      • Contact: Rabia Gokcen Gozubatik Celik; Phone Number: 05549370087; Email: rcelik22@ku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Multiple Sclerosis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
People with MS; 30 People with MS
Health Control; 30 Health Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 0
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	Baseline, Month 6, Month 12

Collaborators and Investigators

• Sponsor: Koç University
• Investigators: Principal Investigator: Rabia G Gozubatik Celik, Assoc. Prof., Koc University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: Vista Protein Expression in MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No