Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)
Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- MSC Treatment
What it measured
Main measures
Adverse events
0,1,2,3,4,12 and 52 weeks post treatment
Safety
Other measures (8)
Visual function (acuity and colour)
12 and 52 weeks post treatment
VisionVisual evoked potential latency
12 and 52 weeks post treatment
Myelin repairOptic nerve Magnetisation Transfer Ratio
12 and 52 weeks post treatment
Myelin repairRetinal nerve fibre layer thickness (by optical coherence tomography)
12 and 52 weeks post treatment
Retina scans (OCT)Brain lesion Magnetisation Transfer Ratio
12 and 52 weeks post treatment
MRI lesionsMyelin repairMRI brain T1 hypointensity load
12 and 52 weeks post treatment
MRI lesionsMultiple Sclerosis Functional Composite Score
12 and 52 weeks post treatment
Expanded Kurtzke Disability Status Score
12 and 52 weeks post treatment
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
* 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 criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Autologous mesenchymal stem cells for the treatment of secondary progressive multiple sclerosis: an open-label phase 2a proof-of-concept study.Lancet Neurol · 2012
Results
The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments.Trials · 2011
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History
Started
Jul 2008
Main results due
Dec 2010
Finished
Dec 2010