NCT00395200

Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
PROCEDURE	MSC Treatment	Intravenous administration of up to 2x10\^6 autologous MSCs per kg

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2006-11-02
• Last updated: 2011-10-25

Locations

2 sites across 1 country: United Kingdom