ABSTRACT NUMBER: ESOC2026YS261 SAFETY AND EFFICACY OF CELL-BASED THERAPIES IN ISCHEMIC STROKE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED TRIALS

Abstract Background and aims Stroke remains a leading cause of long-term disability, with limited treatment options, inadequate neuroprotection, and suboptimal recovery leading to global disability and economic burden. Over the past two decades, cell-based therapies have been investigated as potential modulators of post-stroke repair; however, their clinical efficacy remains uncertain. This meta-analysis evaluates the safety and efficacy of cell-based therapies following ischemic stroke. Methods We conducted a systematic search on PubMed, Embase, Scopus, and Web of Science. Two independent reviewers screened studies and extracted data. Random-effects meta-analyses were used to pool effect estimates for mortality, adverse events, functional outcomes, and neurological recovery. Effect sizes were reported as risk ratios or mean differences with 95% confidence intervals. Prespecified subgroup analyses explored cell source and delivery characteristics. Heterogeneity was assessed using the I2 statistic, and meta-regression analyses were exploratory. Results Nineteen randomized controlled trials were included. Cell therapy was not associated with significant differences in mortality at 3 months (RR 0.88, 95% CI 0.37–2.10) or adverse events at 12 months (RR 0.54, 95% CI 0.18–1.59), supporting an overall favorable safety profile. Across 3, 6, and 12 months, neurological recovery measured by NIHSS showed numerically greater improvement with cell therapy, although pooled effects were not statistically significant; heterogeneity was low across analyses. Subgroup analyses showed no significant differences by cell source, with comparable effects observed for allogeneic approaches. Functional outcomes measured by mRS demonstrated substantial heterogeneity. Most trials evaluated intravenously administered mesenchymal stem cells in the subacute stroke phase, highlighting limited evidence to optimize treatment protocols. Conflict of interest Mohamed Diab: nothing to disclose; Antonio Luna: nothing to disclose; Fiorela Mulellari: nothing to disclose; Halima Şah: nothing to disclose; Vicente Brito: nothing to disclose; Mostafa Elkholy: nothing to disclose; Jonathan Mokhtar: nothing to disclose; Mostafa Meshref: nothing to disclose Figure 1 - belongs to Results