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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