Update: Preliminary results of the mesenchymal stem cell study for the treatment of multiple sclerosis
Background: Mesenchymal stem cell (MSC) therapy is being investigated as a potential treatment for multiple sclerosis (MS). MSCs are found in many places in the body including bone marrow, skin and fat. Studies in animals in the laboratory and preliminary clinical trials in humans have shown promise that MSC treatment is both safe and potentially effective in reducing inflammation and promoting repair. To evaluate MSC as a safe and effective treatment for multiple sclerosis, a team of international researchers conducted a phase II study on mesenchymal stem cells for the treatment of multiple sclerosis across fifteen sites and ten countries. MESCAMS (MEsenchymal Stem cell therapy for CAnadian MS patients) is the Canadian arm of this trial led by Drs. Mark Freedman (The Ottawa Hospital and professor at the University of Ottawa Brain and Mind Research Institute) and James Marriott (Health Sciences Centre Winnipeg and University of Manitoba) and is funded in part by the MS Scientific Research Foundation, Manitoba government and a private donor. The overall aim of this study is to determine if treatment with MSC in people with MS is safe, can reduce harmful inflammation in the brain, and possibly contribute to repair of the central nervous system. One advantage of MSC, is that it does not require intensive chemotherapy as required with the Canadian bone marrow transplantation (BMT) treatment for MS.
The Study: The randomized, double-blind, cross-over clinical trial was conducted across ten countries, including two Canadian sites: The Ottawa Hospital and the Health Sciences Centre Winnipeg on the use of mesenchymal stems cells as a treatment for MS. The trial included participants affected by relapsing-remitting MS in whom existing therapies have not worked optimally, as well as select individuals with secondary and primary progressive forms of MS. Participants were randomly assigned to one of two treatment groups: an early treatment group where participants were given a single infusion of their own MSC at week 0, then given a placebo infusion (sham cells) at week 24; and a late treatment group, where participants were given a single placebo infusion (sham cells) at week 0, then an infusion of their own MSC at week 24 and were followed over 48 weeks. In addition to safety, the study aims to understand any potential clinical benefits of MSC therapy, including reduction of inflammatory injury in the brain as measured by lesions detected by magnetic resonance imaging (MRI), number of relapses, disability progression, and several potential indicators of repair in the central nervous system.
Update: Data from the clinical trial demonstrates that mesenchymal stem cells (MSC) are a safe treatment for people with MS. There was no difference in serious adverse events between those treated with MSC and those who received the placebo (sham cells). The study did not show a statistically significant effect on the primary outcome, the number of contrast enhancing lesions by MRI at 24 weeks in the MSC treatment group. However, there was an important trend towards decreasing relapses in MSC treatment group. Researchers are continuing to analyze the data to better understand other possible outcomes of MSC treatment, including on MRI and other clinical measures, such as effects on myelin repair.
For more information on the international study, please refer to MESEMS.
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