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Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells


filter terms:
  • dendritic cells
  • multiple sclerosis
  • t cell
  • th2 cell
    • Sizes of these terms reflect their relevance to your search.

    • Purpose

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      Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not completely understood.
      We propose that high dose exogenous recombinant IFN-B-1b induces tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the expression of SOCS3 in DCs.


      status: recruiting
      conditions: Multiple Sclerosis
      interventions: INFNb-1b
      phase: Phase 1
      study type: Interventional
      study design: Basic Science, Open Label, Dose Comparison, Single Group Assignment
      official title: Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells

    • Further study details (as provided by The University of North Carolina, Chapel Hill)

      primary outcome measures:

      • Determine the effect of IFN-B-1b-induced SOCS3 upregulation in DCs' on their maturation and the capacity to present [ Time Frame: 2 years ]

      secondary outcome measures:

      • Characterize the effect of IFN-1b-induced SOCS3 expression in DCs on Th1/Th2 cell differentiation and T-cell cytokine transcription. [ Time Frame: 2 years ]

      enrollment: 60

      study start date: September 2007


    • Eligibility

      ages eligible for study: 18 Years to 60 Years
      genders eligible for study: Both

      Criteria

      Inclusion Criteria:
      • Confirmed diagnosis of MS
      • Age 18-60 years, inclusive
      • Expanded disability status of 0-6.5
      • Give written informed consent prior to any testing under this protocol

    • Contacts and locations

      Please refer to this study by its ClinicalTrials.gov identifier: NCT00630721

      Contacts

      Silva Markovic-Plese, MD   919-966-5547   markovics@neurology.unc.edu

      Locations

      United States , North Carolina  - University of North Carolina

      status: recruiting
      facility: Chapel Hill, North Carolina, United States, 27599
      contact: Liseanne Fedor-Hammonds, BS   919-843-7857   hammondsl@neurology.unc.edu

    • Sponsors and collaborators

      The University of North Carolina, Chapel Hill

      investigators: Silva Markovic-Plese, MD, Principal Investigator, UNC Chapel Hill

    • More information

      first received: February 28, 2008
      last updated: June 23, 2009
      ClinicalTrials.gov Identifier: NCT00630721
      health authority: United States: Institutional Review Board

    Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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