The efficacy and safety of mesenchymal stem cell in acute myocardial infarction: a systematic review and meta-analysis of randomized controlled trials

Acute myocardial infarction is a very common type of cardiovascular disease, which seriously endangers patients’ lives and health, significantly increases the incidence of the disease, and imposes a heavy burden on the social economy. However, clinical application protocols for mesenchymal stem cells in individuals with acute myocardial infarction have not yet been established. This meta-analysis aims to systematically assess the comprehensive effects of mesenchymal stem cells in patients with acute myocardial infarction. We conducted a systematic search in PubMed, Web of Science, EMBASE and the Cochrane Library, with the time range covering from the establishment of each database to January 2026. The literature was screened based on the PICOS principle (Population, Intervention, Comparison, Outcome, Study design), and then quality evaluation was carried out to assess the risk of bias. On this basis, data regarding outcome indicators from each study were extracted for combined analysis. The outcomes of concern included cardiac function and adverse events. Statistical analysis was performed using Review Manager 5.4 software, and the quality of the evidence was evaluated using the GRADE method. A total of 12 clinical trials met the inclusion criteria. The pooled analysis indicated improvement in both primary and secondary outcome measures. The results of subgroup analysis showed that compared with the control group, mesenchymal stem cells transplantation in patients with acute myocardial infarction significantly increased LVEF at less than 6 months, 6 months as well as 12 months, significantly decreased LVEDV and LVESV at 6 months, and reduced the WMSI at 12 months. Additionally, the intracoronary and the intravenous routes favored improvements in LVEF. Importantly, mesenchymal stem cell therapy did not increase the risk of major adverse cardiovascular events. Low-to-moderate-certainty evidence suggested that the application of mesenchymal stem cells in the treatment of acute myocardial infarction is both effective and safe. Specifically, this was manifested as an increase in LVEF, and a decrease in LVEDV and LVESV. Although the results of subgroup analysis provided certain references for the rational clinical selection of mesenchymal stem cell treatment, more standardized research is still needed to confirm this.