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

NCT03486665 | Unknown

• 1 other identifier: BIT-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Quantification of disease related white blood cells from blood and/ or CSF

  through study completion, an average of 6 months

Study Arms (3)

Diagnosed with Multiple Sclerosis

Patients previously diagnosed with Multiple Sclerosis

Other: Blood Sampling

Newly Diagnosed with Multiple Sclerosis

Patients diagnosed for the first time with Multiple Sclerosis and hospitalized

Other: Blood Sampling; Other: CSF Sampling

Healthy Volunteers

Health volunteers who do not have an autoimmune diseases, including Multiple Sclerosis

Other: Blood Sampling

Interventions

Blood Sampling OTHER

Blood samples will be taken from all patients and healthy volunteers.

Diagnosed with Multiple Sclerosis; Healthy Volunteers; Newly Diagnosed with Multiple Sclerosis

CSF Sampling OTHER

CSF sample will be taken from hospitalized newly diagnosed patients only.

Newly Diagnosed with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Active malignant disease

Sponsors & Collaborators

• Bioimmunate: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood CSF

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

Sigalit Carmel, MD, MSc

CONTACT

+97225649302; sigalit@bioimmunate.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 3, 2018
• Study Start: April 24, 2018
• Primary Completion: September 1, 2018
• Study Completion: March 1, 2020
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

IL (1)