Efficacy and safety of stem cell therapy vs. standard of care in patients diagnosed with acute respiratory distress syndrome: an updated systematic review and meta-analysis of randomized controlled trials

Objectives This systematic review and meta-analysis aimed to evaluate the efficacy and safety of stem cell therapies as compared to the standard of care (SOC) in patients with acute respiratory distress syndrome (ARDS). Methods Search of PubMed, Embase, Cochrane CENTRAL, and Web of Science databases for randomized controlled trials was performed. The protocol was registered in PROSPERO (ID: CRD42023467612). The primary outcomes were all-cause mortality on day 28 and serious adverse events. Risk ratios (RR) and mean differences were pooled using Stata software version 17.0. Quality of the evidence was assessed by GRADE approach. Results Out of 5,537 articles screened, 17 were included. Treatment with stem cells led to no significant difference in the risk of 28-day mortality [RR, 0.809 (95% CI: 0.651–1.005), p = 0.06; I 2 = 0%] or the risk of serious adverse events [RR, 0.94 (95% CI: 0.80–1.12), p = 0.36; I 2 = 8.58%] as compared to treatment with SOC. Additionally, no significant differences were observed in the duration of hospitalization, the number of ventilator-free days till day 28, 60-day all-cause mortality, intensive care unit (ICU)-free days till day 28, change in quality-of-life (QoL) score, and the duration of ICU stay, PaO 2 /FiO 2 ratio, change in SOFA score, and change in serum interleukin 6 and 8 levels. The GRADE of evidence was low or very low for the critical outcomes. Conclusion There was no significant improvement in critical outcomes following stem cell therapy as compared to the SOC in ARDS. The certainty of evidence was low to very low, indicating limited confidence in the findings. Systematic Trial registration PROSPERO (ID: CRD42023467612)