The MESEMS Clinical Trial

What is a clinical trial?
"… A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc" (WHO – World Health Organization). The goal is to verify that the new therapy is safe, well tolerated, effective, and more efficient than those currently in use.

Clinical trials are typically classified into four phases, each of which has different aims and purposes (Phase I: tolerability, Phase II: efficacy, Phase III: activity, Phase IV: post-marketing surveillance trials). These represent a necessary step before the treatment is approved and commercialized, or made available for therapeutic purposes.

All subjects fulfilling the eligibility criteria specified in the study protocol who decide to participate in a clinical trial choose to have access to a new treatment before it is available to everyone. Thus, they help to achieve medical/scientific progress, by playing an active role in their own health care.

What is MESEMS clinical trial?
MESEMS is a double-blind, randomized, cross-over one year clinical trial, based on an "early" vs "delayed" treatment paradigm. At baseline, about half of the patients will be randomized to receive mesenchymal stem cells and the other half will receive cell culture medium (placebo). After six months, patients who have received MSC will be treated with cell culture medium, and patients who have received placebo will be treated with MSC.
The aim of the trial is to assess the safety and efficacy of intravenous therapy with self mesenchymal stem cells in relapsing MS patients. In addition, a secondary objective is to gather preliminary information of the efficacy of the treatment at various clinical and other levels.