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

• ClinicalTrials.gov Identifier: NCT03486665
• Recruitment Status: Unknown
• First Posted: April 3, 2018
• Last Update Posted: July 19, 2018
• Sponsor: Bioimmunate
• Information provided by (Responsible Party): Bioimmunate

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Multiple Sclerosis	Other: Blood Sampling; Other: CSF Sampling

Study Design

• Study Type: Observational
• Estimated Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Characterization and Quantitative Analysis of White Blood Cells in the Blood and Cerebrospinal Fluid of MS Patients
• Actual Study Start Date: April 24, 2018
• Estimated Primary Completion Date: September 2018
• Estimated Study Completion Date: March 2020

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Quantification of disease related white blood cells from blood and/ or CSF [ Time Frame: through study completion, an average of 6 months ]

Biospecimen Retention:   Samples With DNA

Whole Blood CSF

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Sigalit Carmel, MD, MSc; +97225649302; sigalit@bioimmunate.com

Locations

Israel

Hadassah Medical Center; Recruiting

Jerusalem, Israel

Contact: Ariel Ginzberg, PHD +972 2 6776939

Principal Investigator: Dimitrios Karussis, Prof.

Sponsors and Collaborators

Bioimmunate

More Information

• Responsible Party: Bioimmunate
• ClinicalTrials.gov Identifier: NCT03486665
• Other Study ID Numbers: BIT-001
• First Posted: April 3, 2018
• Last Update Posted: July 19, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases