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Table 1 Eligibility criteria for the ACTiMuS trial

From: Assessment of bone marrow-derived Cellular Therapy in progressive Multiple Sclerosis (ACTiMuS): study protocol for a randomised controlled trial

Inclusion criteria Exclusion criteria
Either sex, 18–65 years old Pregnancy, breastfeeding or lactation
Diagnosis of clinically definite MS as defined by the McDonald criteria History of autologous/allogeneic bone marrow transplantation or peripheral blood stem cell transplant
  Bone marrow insufficiency
MS disease severity EDSS 4–6 History of lymphoproliferative disease or previous total lymphoid irradiation
  Immune deficiency
Disease duration >5 years History of current or recent (<5 years) malignancy
Disease progression (not attributable to relapse) in the year prior to entry Chronic or frequent drug-resistant bacterial infections or presence of active infection requiring antimicrobial treatment
Signed, written informed consent Frequent and/or serious viral infection
Willing and able to comply with study visits according to protocol for the full study period Systemic or invasive fungal disease within 2 years of entry to study
  Significant renal, hepatic, cardiac or respiratory dysfunction
  Contraindication to anaesthesia
Bleeding or clotting diathesis
  Current or recent (within preceding 12 months) immunomodulatory therapy other than corticosteroid therapy
  Treatment with corticosteroids within the preceding 3 months
  Significant relapse within preceding 6 months
  Predominantly relapsing-remitting disease over preceding 12 months
  Radiation exposure in the past year other than chest/dental x-rays
  Previous claustrophobia
The presence of any implanted metal or other contraindication to MRI
  Participation in another experimental study or treatment within previous 24 months