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

NCT06957145 | Recruiting

• 1 other identifier: Vista Protein Expression in MS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis, MS

Outcome Measures

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.

  Baseline, Week 0

Secondary Outcomes (2)

• 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

Study Arms (2)

People with MS

30 People with MS

Health Control

30 Health Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multiple Sclerosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead

Study Sites (2)

Koc University

Istanbul, 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

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rabia G Gozubatik Celik, Assoc. Prof.

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: May 4, 2025
• Study Start: June 30, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)