A Phase 1/2 interventional study of MSC Treatment in Multiple Sclerosis, sponsored by University of Cambridge. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-10-25.
Sponsored by University of Cambridge · Phase 1/2, Interventional, and Treatment
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.
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)
Evidence of optic nerve damage by
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:
Primary
Secondary
Tertiary
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Cambridge is the lead sponsor of 112 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: MSC Treatment
Intravenous administration of up to 2x10\^6 autologous MSCs per kg
Also known as: Mesenchymal Stem Cells, Multipotent Mesenchymal Stem Cells, Multipotent Mesenchymal Stromal Cells
Adverse events
Time frame: 0,1,2,3,4,12 and 52 weeks post treatment
Visual function (acuity and colour)
Time frame: 12 and 52 weeks post treatment
Visual evoked potential latency
Time frame: 12 and 52 weeks post treatment
Optic nerve Magnetisation Transfer Ratio
Time frame: 12 and 52 weeks post treatment
Retinal nerve fibre layer thickness (by optical coherence tomography)
Time frame: 12 and 52 weeks post treatment
Brain lesion Magnetisation Transfer Ratio
Time frame: 12 and 52 weeks post treatment
MRI brain T1 hypointensity load
Time frame: 12 and 52 weeks post treatment
Multiple Sclerosis Functional Composite Score
Time frame: 12 and 52 weeks post treatment
Expanded Kurtzke Disability Status Score
Time frame: 12 and 52 weeks post treatment
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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University of Cambridge