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

Not Applicable

Completed

• Conditions: Progressive multiple sclerosis; Nervous System Diseases; Multiple sclerosis

• Registration Number: ISRCTN27232902
• Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26467901

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-11
• Study Completion: 2017-12-02
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified