MESEMS: Project stem cells in humans

Recent advances in our understanding of stem cell biology, such as the availability of innovative techniques, which allow stem cells to be obtained on a large scale, and the increasing pressure from patients for tissue repair strategies have launched stem cell treatments as one of the most exciting and difficult challenges in the field of multiple sclerosis (MS).

The adult stem/progenitor cells from bone marrow and other tissues referred to as mesenchymal stem cells or multipotent mesenchymal stromal cells (MSC) display a significant therapeutic plasticity as reflected by their ability to enhance tissue repair and influence the immune response both in vitro and in vivo. Pre-clinical experiments in an animal model of MS have demonstrated that intravenous MSC administration induces immune tolerance and promotes neuroprotection.

Thus, current experimental evidence suggests that the sound clinical exploitation of MSC for MS may lead to novel strategies aimed at blocking uncontrolled inflammation, resetting the immune system, protecting neurons and promoting remyelination. Several pilot clinical trials in a small number of subjects with advanced MS have indicated that MSC administration is safe, and have provided an early signal of clinical effectiveness.

The current aim of clinicians and scientists interested in the development of MSC-based strategies for the treatment of MS is to have the ultimate demonstration in large clinical trials that MSC can inhibit CNS inflammation and foster tissue repair as demonstrated clinically with functional recovery, or visualized by magnetic resonance imaging (MRI). As a pre-requisite to achieving this aim, we are conducting a large phase II international multicenter clinical trial (MESEMS) to ascertain the safety of a consensus treatment protocol established by the International Mesenchymal Stem Cells Transplantation Study Group (IMSCTSG) and obtain preliminary information on its efficacy.

Results are expected by early 2016.  


Agencies supporting core activities and coordination

Multiple Sclerosis International Federation (MSIF)

European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

Fondazione Italiana Sclerosi Multipla (FISM)
Agencies supporting national studies

Fondazione Italiana Sclerosi Multipla (FISM)

Fondazione CARIGE - Italy

The Danish Multiple Sclerosis Society - Denmark

UK Multiple Sclerosis Society

UK Stem Cell Foundation

UK Clinical Trials Network

ARSEP Association pour la Recherche sur la Sclérose En Plaques

Vetenskapsrådet, Sweden

Theme Center for Regenerative Medicine, Karolinska Institute, Sweden

Neurology Clinic, Karolinska University Hospital, Stockholm

Institute of Health Carlos III (Badalona)

FIMABIS (Andalusian Public Foundation for Health and Biomedicine Research in Malaga)
Andalusian Initiative for Advanced Therapies - Health and Progress Foundation