Article Text

PDF

143
ACTIMUS—PHASE II CELL THERAPY TRIAL IN PROGRESSIVE MS
  1. Claire M. Rice1,
  2. David I Marks2,
  3. Yoav Ben-Shlomo3,
  4. Nikos Evangelou4,
  5. Paul S Morgan4,
  6. Chris Metcalfe3,
  7. Nick M Kane1,
  8. David A Cottrell1,
  9. Alastair Wilkins1,
  10. Neil J Scolding1
  1. 1Institute of Clinical Neurosciences, University of Bristol, Frenchay Hospital
  2. 2Adult BMT Unit, University Hospitals Bristol NHS Foundation Trust
  3. 3School of Social and Community Medicine, University of Bristol
  4. 4School of Medicine, University of Nottingham

Abstract

We have recently completed a phase I trial of intravenous delivery of autologous bone marrow in progressive MS (‘SIAMMS’). The possibility of repair was suggested by improvements in the neurophysiological secondary outcome measure. The ‘Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis’ (ACTiMuS), due to commence in spring 2014, will examine the efficacy of intravenous delivery of autologous marrow in progressive MS.

A prospective, randomised, double-blind, placebo-controlled, stepped wedge design will be employed at a single centre. Eighty patients with primary (20) or secondary (60) progressive MS will be recruited and randomised to either early (immediate) or late (1 year) intravenous infusion of autologous, filtered bone marrow. The placebo intervention is infusion of autologous blood.

Participants will be followed up for a further year following the final intervention. The primary outcome measure is global evoked potential derived from multimodal evoked potentials. Secondary outcome measures include adverse event reporting, clinical (EDSS and MSFC) and self-assessment (MSIS-29) rating scales, optical coherence tomography (OCT) and brain and spine MRI. Outcomes will be analysed on an intention-to-treat basis. Laboratory studies performed in parallel with the clinical trial will further investigate the biology of bone marrow infusion in MS, including mechanisms underlying repair.

  • EPILEPSY

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.