Mesenchymal Stem Cells in Multiple Sclerosis Trial Protocol
Author Information
Author(s): 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
Primary Institution: Dept. of Clinical Neurosciences, University of Cambridge, UK
Hypothesis
The MSCIMS trial tests the safety and feasibility of treatment with a candidate cell-based therapy for multiple sclerosis.
Conclusion
The MSCIMS trial establishes the safety and feasibility of autologous mesenchymal stem cell therapy in multiple sclerosis and proposes a novel methodology for future neuroprotective trials.
Supporting Evidence
- Ten participants with MS and eight healthy controls were recruited.
- Mesenchymal stem cells were successfully isolated, expanded, and characterized in vitro for all participants in the treatment arm.
- The study aims to inform the design of future studies to address efficacy.
Takeaway
This study is testing a new treatment for multiple sclerosis using special cells from the patient's own body to see if it is safe and can help.
Methodology
The trial uses a phase IIA pre-test : post-test design with autologous mesenchymal stem cells in secondary progressive MS, comparing outcomes with healthy controls.
Potential Biases
Potential bias due to the open-label design and the small number of participants.
Limitations
The study's small sample size may limit the generalizability of the findings.
Participant Demographics
Participants included 10 individuals with secondary progressive MS and 8 healthy controls, with a mean age of 48.8 years.
Statistical Information
P-Value
0.0399
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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