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Previous studies have shown that mesenchymal stem cells (MSCs), also known as mesenchymal stromal cells, based on their immunomodulatory and neuroprotective properties, have been proposed as a promising treatment option for patients with multiple sclerosis
.
Recently, experts from the Department of Neuroscience of the University of Genoa in Italy conducted a MESEMS study to evaluate the safety, tolerability and activity of autologous mesenchymal stem cells derived from bone marrow for the treatment of multiple sclerosis
Previous studies have shown that mesenchymal stem cells (MSCs), also known as mesenchymal stromal cells, based on their immunomodulatory and neuroprotective properties, have been proposed as a promising treatment option for patients with multiple sclerosis
According to the crossover design, patients were randomly assigned (1:1) to receive a single intravenous injection of autologous bone marrow mesenchymal stem cells, and then received a placebo at week 24, or a placebo at week 24, and then received autologous mesenchymal stem cells , And follow up at the 48th week
.
The main goal is to test the safety and activity of MSC treatment
The primary efficacy endpoint was to compare the number of gadolinium-enhanced lesions (GELs) in each treatment group at 4, 12, and 24 weeks
.
The primary efficacy endpoint was evaluated in the complete analysis set after all participants completed the 24th week visit
From July 16, 2012 to July 31, 2019, 144 patients were randomly assigned to receive early intravenous injection of autologous bone marrow mesenchymal stem cells (n=69) or placebo (n=75)
.
Mesenchymal stem cell therapy did not reach the primary efficacy endpoint in the total number of GELs accumulated from baseline to week 24 (ratio [RR] 0.
Mesenchymal stem cell therapy did not reach the primary efficacy endpoint in the total number of GELs accumulated from baseline to week 24 (ratio [RR] 0.
During the study, 213 adverse events were recorded, with similar distribution between groups (35 of 69 patients [51%] recorded 93 cases, while 42 of 75 patients [56%] recorded 120 cases, infusion first Placebo)
Schematic diagram of experimental design
In summary, bone marrow-derived mesenchymal stem cell therapy is safe and well tolerated, but at the 24th week, it has no effect on the GELs of patients with active forms of multiple sclerosis
.
Therefore, this study does not support the use of bone marrow-derived mesenchymal stem cells to treat active multiple sclerosis
In summary, bone marrow-derived mesenchymal stem cell therapy is safe and well tolerated, but at the 24th week, it has no effect on the GELs of patients with active forms of multiple sclerosis
references:
Safety, tolerability, and activity of mesenchymal stem cells versus placebo in multiple sclerosis (MESEMS): a phase 2, randomised, double-blind crossover trial.
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