Abstract
Background: Mesenchymal stem cells (MSCs) shows great potential in the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD). However, the outcomes of clinical trials evaluating the efficiency of MSCs treatment remain controversial, and the long-term benefits remain unclear. Methods: In this systematic review and meta-analysis, we assessed the survival and response after MSCs treatment in SR-aGVHD patients. We searched PubMed, Embase, Cochrane Central, Chinese National Knowledge Infrastructure, Wanfang, the National Diet Library of Japan and J-STAGE for published studies. Both prospective and retrospective studies were included. Response and survival data were extracted independently by three investigators. Pooled outcomes were estimated using a random effects model. Study quality was evaluated using the ROBINS-I tool. Findings: 34 studies comprising 768 patients were included. Pooled overall survival (OS) at the last follow-up was 52% (95% CI 43-61; I²=73%). Pooled survival at 6 months, 1 year and 2 years were 64% (95% CI 57-70; I²=11%), 43% (95% CI 34-53; I²=55%) and 29% (95% CI 19-40; I²=52%), respectively. Overall response rate (ORR) and complete response rate (CRR) were 71% (95% CI 65-76; I²=52%) and 41% (95% CI 33-51; I²=75%), respectively. OS differed significantly with respect to patient age (p=0.008) and MSCs source (p=0.016). Interpretation: Available evidence suggests that MSCs could be an acceptable second-line therapy for SR-aGVHD treatment. Large-scale randomized clinical trials are needed to validate our findings. Funding Statement: This work was supported by Sanming Project of Medicine in Shenzhen (SZSM201412020), Special Funds for the Construction of High Level Hospitals in Guangdong Province (2019), Fund for High Level Medical Discipline Construction of Shenzhen (2016031638), Guangdong Key Laboratory funds of Systems Biology and Synthetic Biology for Urogenital Tumors (2017B030301015). Declaration of Interests: The authors stated: None. Ethics Approval Statement: This systematic review and meta-analysis were prepared according to a prespecified protocol registered with PROSPERO ( number CRD42019139360) for the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) statement.
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