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

Conditions

Progressive multiple sclerosis Nervous System Diseases Multiple sclerosis

Rice CM, Marks DI, Ben-Shlomo Y, Evangelou N, Morgan PS, Metcalfe C, Walsh P, Kane NM, Guttridge MG, Miflin G, Blackmore S, Sarkar P, Redondo J, Owen D, Cottrell DA, Wilkins A, Scolding NJ.

2015-10-1430 citations

10.1186/s13063-015-0953-1

Interventions

Randomisation to early transfusion of autologous marrow and late (12 months) autologous blood infusion or early autologous blood infusion with late (12 months) autologous marrow infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Global evoked potential (GEP)	—

Secondary

Measure	Time frame
1. EDSS and MSFC and MSIS-29 2. Brain and spinal cord magnetic resonance imaging (MRI) with and without gadolinium-enhancement 3. Optical coherence tomography (OCT)	—

Countries

United Kingdom

Outcome results

None listed