Characterization of White Blood Cells Sub-populations From Multiple Sclerosis Patients.

Characterization and Quantitative Analysis of White Blood Cells in the Blood and Cerebrospinal Fluid of MS Patients

Multiple sclerosis (MS) is a chronic progressive neurological autoimmune disease, that gradually affects patient's quality of life. There are about 2.5 millions patients world wide, with an increasing cost Burdon. Up to date, it remains unclear who are the exact cells to initiate the disease. During the disease, the repertoire of cells expands and undergoes changes. The purpose of this study is to characterize those changes.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Blood Sampling; Other: CSF Sampling

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

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Center
    • Contact: Ariel Ginzberg, PHD; Phone Number: +972 2 6776939
    • Principal Investigator: Dimitrios Karussis, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

18 to 70 years old patients with MS defined according to the revised diagnostic criteria of MacDonald and are followed by the neurology or physical medicine and rehabilitation center or healthy volunteers.

Description

Inclusion Criteria:

• Patients with diagnosis of MS according to the revised criteria of McDonald or healthy volunteers
• Ability to provide written informed consent.

Exclusion Criteria:

- Active malignant disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnosed with Multiple Sclerosis; Patients previously diagnosed with Multiple Sclerosis	Other: Blood Sampling; Blood samples will be taken from all patients and healthy volunteers.
Newly Diagnosed with Multiple Sclerosis; Patients diagnosed for the first time with Multiple Sclerosis and hospitalized	Other: Blood Sampling; Blood samples will be taken from all patients and healthy volunteers.; Other: CSF Sampling; CSF sample will be taken from hospitalized newly diagnosed patients only.
Healthy Volunteers; Health volunteers who do not have an autoimmune diseases, including Multiple Sclerosis	Other: Blood Sampling; Blood samples will be taken from all patients and healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantification of disease related white blood cells from blood and/ or CSF	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Bioimmunate

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 1, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

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: BIT-001

Drug and device information, study documents

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