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MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis by Antonio Uccelli; on behalf of the MESEMS study group; Alice Laroni; Lou Brundin; Michel Clanet; Oscar Fernandez; Seyed Massood Nabavi; Paolo A. Muraro; Roberto S. Oliveri; Ernst W. Radue; Johann Sellner; Per Soelberg Sorensen; Maria Pia Sormani; Jens Thomas Wuerfel; Mario A. Battaglia; Mark S. Freedman is a Medicine article available to read on EtoBox.

What is MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis about?

## Background: Multiple sclerosis (ms) is an inflammatory disease of the central nervous system with a degenerative component, leading to irreversible disability. mesenchymal stem cells (msc) have been shown to prevent inflammation and neurodegeneration in animal models of ms, but no large phase ii clinical trials have yet assessed the exploratory efficacy of msc for ms. ## Methods/design: This is an academic, investigator-initiated, randomized, double-blind, placebo-compared phase i/ii clinical trial with autologous, bone-marrow derived msc in ms. enrolled subjects will receive autologous msc at either baseline or at week 24, through a cross-over design. primary co-objectives are to test safety and efficacy of msc treatment compared to placebo at 6 months. secondary objectives will evaluate the efficacy of msc at clinical and mri levels. in order to overcome funding constraints, the mesenchymal stem cells for multiple sclerosis (mesems) study has been designed to merge partially independent clinical trials, following harmonized protocols and sharing some key centralized procedures, including data collection and analyses. ## Discussion: Results will provide patients and the scienti

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Author

Antonio Uccelli; on behalf of the MESEMS study group; Alice Laroni; Lou Brundin; Michel Clanet; Oscar Fernandez; Seyed Massood Nabavi; Paolo A. Muraro; Roberto S. Oliveri; Ernst W. Radue; Johann Sellner; Per Soelberg Sorensen; Maria Pia Sormani; Jens Thomas Wuerfel; Mario A. Battaglia; Mark S. Freedman

Publisher

Springer Science and Business Media LLC

Published

2019

Language

EN

Field

Medicine (Health Sciences)