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Planning stages for worldwide SCT phase III trial

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  • Planning stages for worldwide SCT phase III trial

    This paper is backed by SCT leaders including (former) HALT-MS head Dr. Nash and Dr. Freedman in Ottawa. A randomized phase III study is mandatory to get this into the mainstream. - Dave

    A prospective, randomized, controlled trial of autologous haematopoietic stem cell transplantation for aggressive multiple sclerosis: a position paper

    R Saccardi riccardo.saccardi@aouc.unifi.it
    Hematology Department, Careggi University Hospital, Florence, Italy

    MS Freedman
    Department of Medicine (Neurology), University of Ottawa and the Ottawa Hospital Research Institute, Canada

    MP Sormani
    Department of Health Sciences, University of Genoa, Italy

    H Atkins
    The Ottawa Hospital Blood and Marrow Transplant Programme, The Ottawa Hospital, Canada

    D Farge
    Internal Medicine Department, Saint Louis Hospital, Paris, France

    LM Griffith
    Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, USA

    G Kraft
    Department of Rehabilitation Medicine, University of Washington, USA

    GL Mancardi
    Department of Neuroscience, Ophthalmology and Genetics, University of Genoa, Italy

    R Nash
    Clinical Research Division, Fred Hutchinson Cancer Research Center, and University of Washington, USA

    M Pasquini
    Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, USA

    R Martin
    Department of Clinical Neuroimmunology and MS Research, Neurology Clinic, University Hospital Zürich, Switzerland

    PA Muraro
    Centre for Neuroscience, Imperial College London, UK on behalf of the EBMT, CIBMTR and the HSCT in MS International Study Group

    Abstract

    Background: Haematopoietic stem cell transplantation (HSCT) has been tried in the last 15 years as a therapeutic option in patients with poor-prognosis autoimmune disease who do not respond to conventional treatments. Worldwide, more than 600 patients with multiple sclerosis (MS) have been treated with HSCT, most of them having been recruited in small, single-centre, phase 1–2 uncontrolled trials. Clinical and magnetic resonance imaging outcomes from case series reports or Registry-based analyses suggest that a major response is achieved in most patients; quality and duration of response are better in patients transplanted during the relapsing–remitting phase than in those in the secondary progressive stage.

    Objectives: An interdisciplinary group of neurologists and haematologists has been formed, following two international meetings supported by the European and American Blood and Marrow Transplantation Societies, for the purpose of discussing a controlled clinical trial, to be designed within the new scenarios of evolving MS treatments.

    Conclusions: Objectives of the trial, patient selection, transplant technology and outcome assessment were extensively discussed. The outcome of this process is summarized in the present paper, with the goal of establishing the background and advancing the development of a prospective, randomized, controlled multicentre trial to assess the clinical efficacy of HSCT for the treatment of highly active MS.
    Dave Bexfield
    ActiveMSers

  • #2
    The full article is now available for free and includes references to all current trials including HALT-MS, the trial I am participating in.

    http://msj.sagepub.com/content/18/6/825.full#ref-23
    Dave Bexfield
    ActiveMSers

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