Status:
COMPLETED
Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Medical Research Council
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Hypothesis: Intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple sclerosis. Mesenchymal Stem...
Detailed Description
Disease under investigation: Multiple Sclerosis Phase: I/IIA Number of patients: 10 Design: 18 month cross over, single treatment at 6 months Intervention: Administration of bone marrow-derived au...
Eligibility Criteria
Inclusion
- Clinically definite multiple sclerosis
- Expanded Kurtzke Disability Status Score 2.0 - 6.5 (inclusive)
- Evidence of optic nerve damage by:
- history of optic neuritis, or
- relative afferent pupillary defect, or
- optic atrophy on fundoscopy, or
- abnormal visual evoked potential from either or both eyes suggestive of demyelination
- Prolonged visual evoked potential P100 latency with preserved waveform
- T2 lesion on MRI optic nerve
- Retinal nerve fibre layer thickness on optical coherence tomography \> 40 microns
Exclusion
- Age \< 18 years
- Age \> 65 years
- Patient lacks capacity to give informed consent
- Presence of a severe bleeding disorder
- Planning a pregnancy during the trial period
- Current MS disease modifying therapy
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00395200
Start Date
July 1 2008
End Date
December 1 2010
Last Update
October 25 2011
Active Locations (2)
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1
University of Cambridge Dept of Clinical Neurosciences
Cambridge, Cambridgeshire, United Kingdom, CB2 0PY
2
University College London Institute of Neurology
London, London, United Kingdom, WC1N 3BG