Safety, tolerability, and activity of mesenchymal stem cells versus placebo in multiple sclerosis (MESEMS): a phase 2, randomised, double-blind crossover trial
In RCT (n=144), IV infusion of autologous bone marrow-derived mesenchymal stem cells treatment did not meet primary endpoint of efficacy on total number of gadolinium-enhancing lesions accumulated from baseline to week 24 vs. placebo (rate ratio 0.94, 95% CI 0.58–1.50; p=0.78).
Source:
The Lancet Neurology
SPS commentary:
Commentary notes this is so far the largest randomised, placebo-controlled, phase 2 trial in this area. It discusses the findings of another trial, illustrating not only the potential benefits of this type of therapies in multiple sclerosis but also the tremendous challenges that need to be overcome before this form of personalised cell therapy is ready for wider clinical application. It notes that apart from the issues of standardisation, fundamental questions about the nature of mesenchymal stem cells remain unresolved.