Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2008-2010

ABSTRACT

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 Cells in Multiple Sclerosis (MSCIMS) is a phase I/IIA trial designed to establish the safety of intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells to patients with multiple sclerosis. 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 autologous mesenchymal stem cells Route of administration: Intravenous Dose: Up to 2,000,000 Mesenchymal Stem Cells per kilogram Source of patients: Referrals accepted from Neurologists in East Anglia and North London, UK Referral Criteria: (all 3 required) 1. Clinically definite multiple sclerosis 2. Expanded Kurtzke Disability Status Score 2.0 - 6.5 (inclusive) 3. 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 Primary Objective: Establish the safety of intravenously administered bone marrow-derived autologous mesenchymal stem cells at a dose of up to 2,000,000 cells/kg over 12 months by monitoring adverse reactions. Secondary Objectives: Explore the efficacy of intravenously administered bone marrow-derived autologous mesenchymal stem cells at a dose of up to 2,000,000 cells/kg over 12 months on visual function by clinical, neurophysiological, and imaging assessments. Outcome Measures: 1. Primary - Adverse events 2. Secondary - Visual function (acuity and colour) - Visual evoked potential latency - Optic nerve Magnetisation Transfer Ratio - Retinal nerve fibre layer thickness (by optical coherence tomography) - Brain lesion Magnetisation Transfer Ratio - MRI brain T1 hypointensity load - T cell response suppression 3. Tertiary - Multiple Sclerosis Functional Composite Score - Expanded Kurtzke Disability Status Score More... »

URL

https://clinicaltrials.gov/show/NCT00395200

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