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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03486665
• Other study ID #: BIT-001
• Status: Recruiting
• Start date: April 24, 2018
• Est. completion date: March 2020

Study information

• Verified date: July 2018
• Source: Bioimmunate
• Contact: Sigalit Carmel, MD, MSc
• Phone: +97225649302
• Email: sigalit[@]bioimmunate.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Blood Sampling
Blood samples will be taken from all patients and healthy volunteers.
• CSF Sampling
CSF sample will be taken from hospitalized newly diagnosed patients only.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Bioimmunate

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of disease related white blood cells from blood and/ or CSF		through study completion, an average of 6 months