Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2008-07-31
2010-12-31
Brief Summary
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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
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MSC Treatment
MSC Treatment
Intravenous administration of up to 2x10\^6 autologous MSCs per kg
Interventions
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MSC Treatment
Intravenous administration of up to 2x10\^6 autologous MSCs per kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 \> 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
18 Years
65 Years
ALL
No
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
Medical Research Council
OTHER_GOV
University of Cambridge
OTHER
Responsible Party
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Peter Connick
Research Associate
Principal Investigators
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Siddharthan Chandran, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Locations
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University of Cambridge Dept of Clinical Neurosciences
Cambridge, Cambridgeshire, United Kingdom
University College London Institute of Neurology
London, London, United Kingdom
Countries
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References
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Connick P, Kolappan M, Patani R, Scott MA, Crawley C, He XL, Richardson K, Barber K, Webber DJ, Wheeler-Kingshott CA, Tozer DJ, Samson RS, Thomas DL, Du MQ, Luan SL, Michell AW, Altmann DR, Thompson AJ, Miller DH, Compston A, Chandran S. 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 Mar 2;12:62. doi: 10.1186/1745-6215-12-62.
Connick P, Kolappan M, Crawley C, Webber DJ, Patani R, Michell AW, Du MQ, Luan SL, Altmann DR, Thompson AJ, Compston A, Scott MA, Miller DH, Chandran S. Autologous mesenchymal stem cells for the treatment of secondary progressive multiple sclerosis: an open-label phase 2a proof-of-concept study. Lancet Neurol. 2012 Feb;11(2):150-6. doi: 10.1016/S1474-4422(11)70305-2. Epub 2012 Jan 10.
Related Links
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University of Cambridge Dept. of Clinical Neurosciences
UCL Institute of Neurology
Study protocol and baseline characteristics of the cohort
Other Identifiers
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REC Reference: 07/Q0108/104
Identifier Type: -
Identifier Source: secondary_id
MRCRG44871
Identifier Type: -
Identifier Source: org_study_id