SCLEROLYM ( DrugBank: - )

1 disease
告示番号疾患名（ページ内リンク）臨床試験数
13多発性硬化症／視神経脊髄炎2

13. 多発性硬化症／視神経脊髄炎

臨床試験数 : 3,342 /  薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT02427776
(ClinicalTrials.gov)		January 20152/4/2015A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple SclerosisA Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimulated and Expanded ex Vivo by a Myelin Oligodendrocyte Glycoprotein Peptide Modified by the Introduction of a Thioreductase Motif Into the Flanking Residues of the Cell Epitope - A First-in-human Trial (SCLEROLYM TRIAL)Multiple Sclerosis, Relapsing-RemittingBiological: Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitopeImcyse SANULLTerminated18 Years50 YearsAll2Phase 1/Phase 2Belgium
2EUCTR2014-001081-99-BE
(EUCTR)		16/12/201403/12/2014A first in human trial for evaluating both safety and preliminary efficacy of a single infusion of stimulated autologous CD4+ cells in patients with Relapsing- Remitting multiple sclerosisA clinical trial to document safety and radiological disease activity in patients with relapsing-remitting multiple sclerosis treated with autologous CD4+ cells, stimulated and expanded ex vivo by a myelin oligodendrocyte glycoprotein (MOG) peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope (SCLEROLYM trial).First-in-human trial - SCLEROLYM Trial Multiple sclerosis is an immune-mediated inflammatory disease that attacks myelinated axons in the central nervous system. MS is characterized initially by episodes of reversible neurologic deficits. In most patients, these episodes are followed by progressive neurologic deterioration over time. Relapsing-remitting multiple sclerosis is characterized by recurrent attacks of neurologic dysfunction (relapses) followed by periods of complete or incomplete recovery (remission)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: SCLEROLYM
INN or Proposed INN: Cytolytic CD4+ T cells
Other descriptive name: AUTOLOGOUS T-LYMPHOCYTES		ImCyse S.ANULLNot RecruitingFemale: yes
Male: yes		Phase 1;Phase 2Belgium