Mesenchymal Stem Cells Versus Placebo for Perianal Fistulizing Crohn’s Disease: A Systemic Review and Meta-Analysis

Abstract

Background Mesenchymal stem cells (MSCs)-based therapy for perianal fistulizing Crohn’s disease (pfCD) has been extensively studies in the past decade. Its efficacy and safety had been preliminarily confirmed in some phase 2 or phase 3 clinical trials. This meta-analysis is performed to evaluate the efficacy and safety of MSCs-based therapy for pfCD. Methods Electronic databases (Pubmed, Cochrane Library, Embase) were searched for studies that reported the efficacy and safety of MSCs. And RevMan were used to assess the efficacy and safety. Results After screening, 5 randomized controlled trials (RCTs) were included in this meta-analysis. RevMan 5.4 for meta-analysis showed that: [Efficacy] Patients had definite remission after MSCs treatment, with an odds ratio (OR) of 2.06 ( P < .0001, 95%CI 1.46, 2.89) vs controls. [Safety] The incidence of the most frequently reported TEAEs (treatment-emergent adverse events, TEAEs), perianal abscess and proctalgia, did not significantly increase due to the use of MSCs, with an OR of 1.07 in perianal abscess ( P = .87, 95%CI 0.67, 1.72) vs controls, and an OR of 1.10 in proctalgia ( P = .47, 95%CI 0.63, 1.92) vs controls. Conclusions MSCs seem to be an effective and safe therapy for pfCD. MSCs based therapy has the potential to be used in combination with traditional therapies.