Status:
UNKNOWN
Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS)
Lead Sponsor:
North Bristol NHS Trust
Collaborating Sponsors:
Bristol Royal Hospital for Children
University of Bristol
Conditions:
Progressive Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Multiple sclerosis - MS - affects 1.3m people worldwide, costing the European Union economy €9 billion/year, through both direct and indirect consequences of progressive disability. Despite the usual ...
Detailed Description
The primary objective is to determine whether autologous bone marrow (BM) (ie taken from the patients themselves rather than from a BM donor) cell therapy is truly beneficial in chronic multiple scler...
Eligibility Criteria
Inclusion
- Diagnosis of clinically-definite MS as defined by the McDonald criteria
- Aged 18 - 65 years.
- EDSS of 4.0 to 6 inclusive
- Disease duration \>5 years
- Disease progression (increase in physical disability, not due to major relapse) in preceding year
- Signed, written informed consent
- Willing and able to comply with study visits according to protocol for the full study period
Exclusion
- Pregnancy, breastfeeding or lactation
- History of autologous/allogenic bone marrow transplantation or peripheral blood stem cell transplant
- Bone marrow insufficiency
- History of lymphoproliferative disease or previous total lymphoid irradiation
- Immune deficiency
- Current or recent (\<5 years) malignancy
- Chronic or frequent drug-resistant bacterial infections or presence of active infection requiring antimicrobial treatment
- Frequent and/or serious viral infection
- 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 three 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 the preceding 24 months
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01815632
Start Date
January 1 2014
End Date
October 1 2019
Last Update
June 27 2018
Active Locations (1)
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1
Southmead Hospital
Bristol, United Kingdom, BS10 5NB