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Results of International Mesenchymal Stem Cell Trial Suggest No Benefits Against Inflammation in Active MS

November 4, 2021

Results have been published from a phase 2 clinical trial conducted at 15 sites in 9 countries, testing the ability of mesenchymal stem cells (MSCs) to reduce new inflammation seen on MRI brain scans of people with relapsing. The procedure was found to be safe, but it did not reduce the risk of active brain lesions, which was the main endpoint established for this trial. 
  • Background: MSCs are adult stem cells found in several places in the body, including bone marrow, skin, and fat tissue. They are under investigation in MS because laboratory studies have suggested they can reduce immune activity, protect the nervous system from damage, and promote a tissue environment favorable to natural myelin repair processes.
  • The “MESEMS” (MEsenchymal StEm cells for Multiple Sclerosis) trial involved 144 people up to 50 years of age with active (suggestive of ongoing inflammation) relapsing or active progressive MS. They infused participants’ own MSCs derived from their bone marrow and monitored results after 24 weeks. As a control, those randomly assigned to begin on placebo were later switched to MSCs, and those originally given MSCs were switched to placebo.
  • After all participants had received MSCs, the total number of active (gadolinium-enhancing) lesions accumulated over 24 weeks was compared between the placebo period and the treatment period. There was no statistically significant difference between groups by this measure. MSC treatment was found to be safe and well tolerated.
  • Note: This trial was not designed to assess the activity of MSC treatment on tissue repair or on slowing of disability. There are ongoing clinical trials of MSCs in MS, including ones focusing on augmenting nervous system repair, and ones that manipulate the cells to become more specialized stem cells that secrete many different potentially beneficial nervous system growth factors. Read more about ongoing research in mesenchymal stem cells for MS
  • The study was funded by many health and MS-focused agencies in Canada and Europe.
 
“Safety, tolerability, and activity of mesenchymal stem cells versus placebo in multiple sclerosis (MESEMS): a phase 2, randomised, double-blind crossover trial,” by Antonio Uccelli, Alice Laroni, Rehiana Ali, Mario Alberto Battaglia, Morten Blinkenberg, Lou Brundin, Michel Clanet, Oscar Fernandez, James Marriot, Paolo Muraro, Seyed Massood Nabavi, Roberto S Oliveri, Ernst Radue, Cristina Ramo Tello, Irene Schiavetti, Johann Sellner, Per Soelberg Sorensen, Maria Pia Sormani, Jens Thomas Wuerfel, Mark S Freedman, on behalf of the MESEMS investigators, was published in Lancet Neurology (2021; 20: 917–29).
 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.

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