T Cell Profiling in Patients With Multiple Sclerosis

Sponsor

Boston Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04789551

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Blood Sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

T Cell Profiling in Patients With Multiple Sclerosis

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

T cell populations [up to one week]
compare T cell populations between patients with Multiple Sclerosis and healthy controls

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hopsital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lifei Hou, Principal Investigator, Boston Children's Hospital

ClinicalTrials.gov Identifier:

NCT04789551

Other Study ID Numbers:

IRB-P00037843

First Posted:

Mar 9, 2021

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Aug 9, 2022