An observational study in Multiple Sclerosis, sponsored by University College, London. Status unknown at 2 sites in United Kingdom. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by University College, London · Observational
The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS.
In Multiple Sclerosis (MS) immune cells recognise myelin, the coating around nerve fibres, as a foreign molecule and attack it by mistake; at the same time regulatory immune cells (which are normally protective) do not work properly and cannot block the harmful effects of the activated immune cells effectively.
Immune cells work via a complex system of signals that start on the outside layer of the cell (the plasma membrane), these signals are transmitted inside the cell where they trigger immune cell activation. The plasma membrane consists of a fatty layer and changes in the type of fat in the membrane can affect immune cell signalling and immune cell function.
The aims of this project are to:
Methods: This research study involves collecting participant demographic and clinical information, blood and Cerebral Spinal Fluid (CSF) (optional) from patients with MS. Blood will also be collected from healthy volunteers for comparison. Experiments will be performed on the blood samples and the results correlated with the clinical and disease features of patients.
Outcomes: Many of the molecules involved in the generation of fats are well known and for some of them drugs are already used in humans to treat diseases (for example statins). This could allow the rapid translation of the results from this study to the clinic and have a direct impact for people with MS.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 275 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Those with and those without MS
Exclusion Criteria:
Healthy donors ONLY: will be excluded from the study if:
Newly presenting Clinically Isolated Syndrome (CIS) or Relapsing and Remitting Multiple Sclerosis (RRMS) patients not treated before with Disease Modifying Drugs (DMD) Additional analysis of CSF and CSF cells will be performed in this cohort on a voluntary basis.
Other: Blood sampling
People with confirmed diagnosis of SPMS
Other: Blood sampling
People with confirmed diagnosis of PPMS
Other: Blood sampling
People with Multiple Sclerosis (MS) who are treated with DMD who have had stable disease symptoms for at least 3 months
Other: Blood sampling
People who undergo lumbar puncture due to clinical suspicion of neurological condition, but brain Magnetic Resonance Imaging (MRI) and CSF examination exclude MS diagnosis.
Other: Blood sampling
Age, sex and ethnicity matched healthy donors will also be recruited from university and hospital staff and patient friends after informed consent has been obtained. Healthy donors will be asked to provide a blood sample and demographic information but will NOT be asked to provide CSF samples.
Other: Blood sampling
Blood sampling +/- CSF sampling
Also known as: CSF sampling
Lipid Phenotyping (1)
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London (UCL), Rayne Building for lipid phenotyping of PBMC using flow cytometry
Time frame: 4 hours from point of sample collection
Lipid Phenotyping (2)
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for lipid phenotyping of PBMC using measurement of quantitative polymerase chain reaction (qPCR)
Time frame: 4 hours from point of sample collection
Analysis of immune cell function
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function using flow cytometry.
Time frame: 4 hours from point of sample collection
Analysis of cytokine
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of cytokine using flow cytometry.
Time frame: 4 hours from point of sample collection
Analysis of immune cell function (1)
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function through cell culture.
Time frame: 4 hours from point of sample collection
Analysis of immune cell function (2)
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function through flow cytometry.
Time frame: 4 hours from point of sample collection
Analysis of serum
Blood samples collected from consented participants containing serum will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for measurement of chemokine, lipid expression and expression of other molecules important for immune cell activation.
Time frame: 4 hours from point of sample collection
Plan to share: Undecided — All participants indicate by written consent if they are willing to allow any of their un-used samples and associated data to be used for future research MS related research.
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University College, London