T Cell Profiling in Patients with Multiple Sclerosis

NCT04789551 | Not Yet Recruiting

• 1 other identifier: IRB-P00037843
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• T cell populations

  compare T cell populations between patients with Multiple Sclerosis and healthy controls

  up to one week

Study Arms (3)

Multiple Sclerosis Stable Conditions

Multiple sclerosis patients presenting for a routine clinic visit.

Other: Blood Sample

Multiple Sclerosis Acute Flare Up

Multiple sclerosis patients admitted to the hospital with acute symptoms.

Other: Blood Sample

Control patients

Patients without any immunological diseases who present for elective surgery.

Other: Blood Sample

Interventions

Blood Sample OTHER

a blood sample will be collected

Control patients; Multiple Sclerosis Acute Flare Up; Multiple Sclerosis Stable Conditions

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Have an active infection
• Take T cell modulating drugs
• Have an active infection.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Lifei Hou, PhD

CONTACT

617-713-8154; lifei.hou@childrens.harvard.edu

Study Design

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

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: June 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)