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In the present study, we, the investigators at Sheba Medical Center, intend to evaluate T cell vaccination (TCV) in patients with probable multiple sclerosis (MS) within up to 3 months after the first clinical attack. It is of the utmost importance to evaluate the treatment effects at the onset of disease, i.e. in patients with probable MS, in order to evaluate whether early treatment can prevent the second attack (conversion to definite MS). Moreover, at disease onset, the immunological process of epitope spreading associated with the exposure of the immune system to myelin antigens is still limited. With additional attacks, increased recognition of new self-determinants of encephalitogenic peptides presented to the immune system during the inflammatory process occurs, and enhances further disease activity. The aim of the early TCV treatment approach is to stop this process as early as possible, during the onset of the disease, thus preventing additional attacks and disease progression.
We will evaluate the effect of TCV on clinical, immunological and magnetic resonance imaging (MRI) parameters in patients with probable MS.
Inclusion criteria:
Exclusion criteria:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T cell vaccination | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of progression to definite MS (second attack) during the study | ||
| Time to progression to definite MS (second attack) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the count of new gadolinium (GD) enhancing lesions from two baseline (B) MRIs to the final (F) MRIs | ||
| Change in total volume of new GD enhancing lesions from two baseline MRIs (B) to the final MRIs (F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anat Achiron, MD, PhD | Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel | Principal Investigator |
| Mathilda Mandel, MD | Blood Bank, Sheba Medical Center, Tel-Hashomer, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Ramat Gan | 52621 | Israel |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| The change in neurological disability as measured by the Expanded Disability Status Scale (EDSS) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |