Age
Item
males and females 18 to 50 years of age
boolean
C0001779 (UMLS CUI [1])
Episode of Disease | Relapse
Item
patients closely followed up for at least one year prior to inclusion (i.e. prior to the start of the baseline phase) if the diagnosis of the disease was made more than one year ago, to ensure that all possible episodes of clinical relapses which occurred during this interval of time were recorded and documented
boolean
C0332189 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2])
Multiple Sclerosis
Item
multiple sclerosis that meets the 2010 revised mcdonald criteria
boolean
C0026769 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Clinically isolated syndrome | Diagnostic Imaging | Lesion of brain
Item
relapsing/remitting type of multiple sclerosis (which includes clinically isolated syndromes if imaging shows brain lesions disseminated in space and time)
boolean
C0751967 (UMLS CUI [1])
C2921627 (UMLS CUI [2])
C0011923 (UMLS CUI [3])
C0221505 (UMLS CUI [4])
Onset of illness | Multiple Sclerosis Symptom First
Item
disease onset, defined as date of first symptom suggestive for multiple sclerosis, not older than 10 years
boolean
C0277793 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Active disease diagnosis Radiologic examination | Gadolinium-Enhancing Lesion | magnetic resonance imaging of head: T1-weighted MRI brain procedure
Item
radiologically active disease defined by at least one gadolinium-enhancing lesion on a t1-weighted magnetic resonance imaging brain scan performed recently (i.e. within 3 months prior to inclusion)
boolean
C2707252 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C1333400 (UMLS CUI [2])
C2029669 (UMLS CUI [3,1])
C0412675 (UMLS CUI [3,2])
Biological Response Modifier Therapy | beta-1 Interferon | glatiramer acetate | dimethyl fumarate
Item
disease-modifying drug naïve patients or patients with stable and adequately taken disease-modifying therapy (interferon β-1, glatiramer acetate, or dimethyl fumarate) for at least six months before inclusion (note: other disease modifying drugs might be added at a later date, depending on the results of current investigations)
boolean
C0005527 (UMLS CUI [1])
C0005148 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C0058218 (UMLS CUI [4])
Kurtzke multiple sclerosis rating scale
Item
edss score <= 5.5
boolean
C0451246 (UMLS CUI [1])
HLA-DRB1*1501 antigen Positive
Item
positive for the hla drb1*1501 allele
boolean
C1506200 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Positive Predictive Value of Diagnostic Test in vitro | Cell positive for CD4 antigen Reactivity Peptide immunogenic
Item
positive predictive test in vitro for patient's cd4+ cell reactivity to immunogenic peptide
boolean
C1514243 (UMLS CUI [1,1])
C1533691 (UMLS CUI [1,2])
C3251824 (UMLS CUI [2,1])
C0443286 (UMLS CUI [2,2])
C0030956 (UMLS CUI [2,3])
C0872192 (UMLS CUI [2,4])
Childbearing Potential Age | Pregnancy test negative | Contraceptive methods | Leukapheresis
Item
women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment and follow-up phase of the study (three pregnancy tests will be required prior to and during the study: (1) during the screening phase, (2) about one week prior to leukapheresis, and (3) about one week prior to re-infusion of autologous cells)
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0427780 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0023416 (UMLS CUI [4])
Informed consent
Item
fully informed written consent obtained
boolean
C0021430 (UMLS CUI [1])
Relapse | Intravenous steroid injection | Oral steroid therapy
Item
evidence of clinical relapse and use of intravenous or oral corticosteroids within 30 days prior to inclusion
boolean
C0035020 (UMLS CUI [1])
C0563322 (UMLS CUI [2])
C0574135 (UMLS CUI [3])
Therapeutic procedure Complex Anticipated | Biological Response Modifier Therapy Change | Immunotherapy
Item
therapeutic escalation anticipated (including change of disease modifying drug), other than the cell-based immunotherapy of this study, within the next six months
boolean
C0087111 (UMLS CUI [1,1])
C0439855 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
C0005527 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3])
Co-morbid condition | Systemic disease | Renal Insufficiency
Item
significant coexisting systemic disease including renal insufficiency
boolean
C1275743 (UMLS CUI [1])
C0442893 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Serology positive Hepatitis B | Serology positive Hepatitis C | Serology positive AIDS | Serology positive Syphilis
Item
positive serology for hepatitis b and c, aids and syphilis
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0001175 (UMLS CUI [3,2])
C0242089 (UMLS CUI [4,1])
C0039128 (UMLS CUI [4,2])
Study Subject Participation Status
Item
participation in another interventional clinical study, currently or during the past three months
boolean
C2348568 (UMLS CUI [1])