Assessment of bone marrow-derived Cellular Therapy in progressive Multiple Sclerosis (ACTiMuS)

orth Bristol NHS Trust (UK)0 个研究点目标入组 80 人开始时间: 2012年9月11日最近更新: 2019年2月11日

适应症

试验速览

•1. Subject of either sex, 18 to 60 years (inclusive)
•2. Diagnosis of clinically-definite MS as defined by the McDonald criteria
•3. MS disease severity EDSS 4 ? 6
•4. Disease duration >5 years
•5. Disease progression (not attributable to relapse) in the year prior to entry
•6. Signed, written informed consent
•7. Willing and able to comply with study visits according to protocol for the full study period

•1. Pregnancy, breastfeeding or lactation
•2. History of autologous/allogeneic bone marrow transplantation or peripheral blood stem cell transplant
•3. Bone marrow insufficiency
•4. History of lymphoproliferative disease or previous total lymphoid irradiation
•5. Immune deficiency
•6. History of current or recent (<5 years) malignancy
•7. Chronic or frequent drug-resistant bacterial infections or presence of active infection requiring antimicrobial treatment
•8. Frequent and/or serious viral infection
•9. Systemic or invasive fungal disease within 2 years of entry to study
•10. Significant renal, hepatic, cardiac or respiratory dysfunction
•11. Contraindication to anaesthesia
•12. Bleeding or clotting diathesis
•13. Current or recent (within preceding 12 months) immunomodulatory therapy other than corticosteroid therapy
•14. Treatment with corticosteroids within the preceding 3 months
•15. Significant relapse within preceding 6 months
•16. Predominantly relapsing-remitting disease over preceding 12 months
•17. Radiation exposure in the past year other than chest / dental x-rays
•18. Previous claustrophobia
•19. Presence of implanted metal or other contraindication to MRI
•20. Participation in another experimental study or treatment within previous 24 months

发起方

orth Bristol NHS Trust (UK)