CClinicalTrials.gg
Status unknownNCT03486665Updated Jul 19, 2018

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

An observational study in Multiple Sclerosis, sponsored by Bioimmunate. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Bioimmunate · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis
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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • Active malignant disease
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherBlood Sampling

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

  • OtherCSF Sampling

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

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What researchers measure

Primary outcomes

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

    Time frame: through study completion, an average of 6 months

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Study locations

1 of 1 sites recruiting
  • Hadassah Medical Center
    Jerusalem, Israel
    • Ariel Ginzberg, PHD · Contact · +972 2 6776939
    • Dimitrios Karussis, Prof. · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03486665
Lead sponsor
Bioimmunate
Responsible party
Sponsor
First posted
Apr 3, 2018
Start date
Apr 24, 2018
Primary completion
Sep 2018 (estimated)
Completion
Mar 2020 (estimated)
Last update
Jul 19, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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