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

Background No treatments are currently available that slow, stop, or reverse disease progression in established multiple sclerosis (MS). The Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) trial tests the safety and feasibility of treatment with a candidate cell-based therapy, and will inform...

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Published in:Current controlled trials in cardiovascular medicine Vol. 12; no. 1; p. 62
Main Authors: Connick, Peter, Kolappan, Madhan, Patani, Rickie, Scott, Michael A, Crawley, Charles, He, Xiao-Ling, Richardson, Karen, Barber, Kelly, Webber, Daniel J, Wheeler-Kingshott, Claudia AM, Tozer, Daniel J, Samson, Rebecca S, Thomas, David L, Du, Ming-Qing, Luan, Shi L, Michell, Andrew W, Altmann, Daniel R, Thompson, Alan J, Miller, David H, Compston, Alastair, Chandran, Siddharthan
Format: Journal Article
Language:English
Published: London BioMed Central 02.03.2011
BioMed Central Ltd
Springer Nature B.V
BMC
Subjects:
Adult
Biomedicine
Bone marrow
Care and treatment
Cell Proliferation
Cells, Cultured
Disability Evaluation
England
Factories
Feasibility Studies
Female
Health Sciences
Hepatitis
Humans
Magnetic Resonance Imaging
Male
Manufacturing
Medicine
Medicine & Public Health
Mesenchymal Stem Cell Transplantation - adverse effects
Mesenchymal Stem Cells - physiology
Methodology
Middle Aged
Multiple sclerosis
Multiple Sclerosis, Chronic Progressive - diagnosis
Multiple Sclerosis, Chronic Progressive - surgery
Optic nerve
Patient outcomes
Research Design
Risk Assessment
Statistics for Life Sciences
Stem cells
Time Factors
Transplantation
Transplantation, Autologous
Treatment Outcome
United Kingdom
United Kingdom > UK
Optical Coherence Tomography
Retinal Nerve Fibre Layer
Retinal Nerve Fibre Layer Thickness
Magnetisation Transfer Ratio
Diffusion Tensor Imaging
ISSN:1745-6215, 1745-6215
Online Access:Get full text
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Summary:Background No treatments are currently available that slow, stop, or reverse disease progression in established multiple sclerosis (MS). The Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) trial tests the safety and feasibility of treatment with a candidate cell-based therapy, and will inform the wider challenge of designing early phase clinical trials to evaluate putative neuroprotective therapies in progressive MS. Illustrated by the MSCIMS trial protocol, we describe a novel methodology based on detailed assessment of the anterior visual pathway as a model of wider disease processes - the "sentinel lesion approach". Methods/design MSCIMS is a phase IIA study of autologous mesenchymal stem cells (MSCs) in secondary progressive MS. A pre-test : post-test design is used with healthy controls providing normative data for inter-session variability. Complementary eligibility criteria and outcomes are used to select participants with disease affecting the anterior visual pathway. Results Ten participants with MS and eight healthy controls were recruited between October 2008 and March 2009. Mesenchymal stem cells were successfully isolated, expanded and characterised in vitro for all participants in the treatment arm. Conclusions In addition to determining the safety and feasibility of the intervention and informing design of future studies to address efficacy, MSCIMS adopts a novel strategy for testing neuroprotective agents in MS - the sentinel lesion approach - serving as proof of principle for its future wider applicability. Trial registration ClinicalTrials.gov ( NCT00395200 ).
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ISSN:1745-6215
1745-6215
DOI:10.1186/1745-6215-12-62