T Cell Profiling in Patients With Multiple Sclerosis

The goal of this research study is to to learn more about the body's immune response in patients with multiple sclerosis (MS). In MS, the body's immune cells mistakenly attack an important part of the nerves of the brain and spinal cord. The immune cells responsible for attacking the nerves in MS patients is primarily the T cells. A marker was recently discovered that might specifically identify these damaging T cells from all other T cells in the body. Understanding which T cells cause the damage in MS patients and understanding more about these specific T cells may help doctors better understand how MS occurs and could possibly prevent MS in the future.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Blood Sample

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Lifei Hou, PhD; Phone Number: 617-713-8154; Email: lifei.hou@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hopsital
      • Contact: Koichi Yuki, MD; Phone Number: 617-355-6225; Email: koichi.yuki@childrens.harvard.edu
      • Contact: Lifei Hou, PhD; Email: lifei.hou@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Multiple Sclerosis who present to Boston Children's Hospital will be enrolled. A group of healthy control patients who present for elective surgery at Boston Children's Hospital will also be enrolled.

Description

MS Group Inclusion criteria

-diagnosis of multiple sclerosis and present to the neurology clinic for a regular checkup or are admitted to the inpatient floor with acute symptoms.

Exclusion criteria

• Have an active infection
• Take T cell modulating drugs

Control Group Inclusion criteria -scheduled for elective surgery

• without any immunological diseases. Exclusion criteria
• Have an active infection.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiple Sclerosis Stable Conditions; Multiple sclerosis patients presenting for a routine clinic visit.	Other: Blood Sample; a blood sample will be collected
Multiple Sclerosis Acute Flare Up; Multiple sclerosis patients admitted to the hospital with acute symptoms.	Other: Blood Sample; a blood sample will be collected
Control patients; Patients without any immunological diseases who present for elective surgery.	Other: Blood Sample; a blood sample will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T cell populations	compare T cell populations between patients with Multiple Sclerosis and healthy controls	up to one week

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: IRB-P00037843

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No