Preliminary Results Show Mesenchymal Stem Cell Therapy in Multiple Sclerosis is Safe
Ongoing data analysis will look for effects on regeneration and repair
October 10, 2019 – Early data from the international clinical trial on the use of MEsenchymal StEm cells for Multiple Sclerosis (MESEMS) as a treatment for MS were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in September. The study demonstrated 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 the 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.
MSCs are found in many places in the body including bone marrow, skin and fat. They have been demonstrated to suppress inflammation and repair nerve tissue, positioning them as promising candidates for the treatment of MS.
Preliminary data were presented at ECTRIMS by Dr. Antonio Uccelli, Scientific Director of San Martino Hospital, Genoa, co-principal investigator along with Dr. Mark Freedman, a neurologist and Director of MS Research at The Ottawa Hospital and professor at the University of Ottawa Brain and Mind Research Institute. MESCAMS (MEsenchymal Stem cell therapy for CAnadian MS patients) is the Canadian arm of this clinical trial led by Dr. Freedman and Dr. James Marriott (Health Sciences Centre Winnipeg and University of Manitoba) and was funded in part by the MS Scientific Research Foundation, Research Manitoba, A&W Food Services of Canada Inc., and a private donor.
“This clinical trial was a tremendous international effort that required involvement and support from a number of researchers, funders and people living with MS. Understanding that mesenchymal stem cells are a safe treatment option for MS is an important milestone and outcome of the trial,” says Dr. Freedman. “We’re hopeful that further investigation of the data will provide insight into whether there is a link between participants that demonstrated a biological effect from MSC treatment, either reduced MRI lesions or relapses, with evidence of repair.”
The phase II, randomized, double-blind, placebo-controlled cross-over study engaged participants in Canada at two sites: The Ottawa Hospital and Health Sciences Centre Winnipeg. Participants were people with relapsing-remitting MS for whom existing therapies have not been optimal, as well as select individuals with secondary and primary progressive forms of MS. Over the course of the study, these participants were assessed for side effects as well as any potential clinical benefits of MSC therapy, including reduced brain inflammation, number of relapses, disability progression and other indicators of potential repair in the central nervous system (CNS).
“This trial has shown that mesenchymal stem cells are safe; now we need to fully analyze all the data to see if there is a positive signal to better drive further research and trials.” said Dr. Marriott. “The development of innovative therapies such as these is critical for the more than 77,000 Canadians who live with MS.”
“Treatment options involving stem cells are showing real promise for people living with MS. We are proud to be investing in research examining mesenchymal stem cells as a treatment option. We look forward to learning more about the study outcomes once the analysis is complete. We are pleased to support Canadian researchers, who are helping lead the way in developing and exploring new treatment options for people with MS,” says Dr. Pamela Valentine, president and CEO, MS Society of Canada.
The researchers are currently in the process of analyzing all of the data and will share their additional findings in the coming months.
Read more about the MESCAMS study.