Background:
Burn injuries present a major clinical challenge due to their complexity and the limitations of conventional treatments in restoring functional and aesthetic skin. Stem cell-based therapies offer promising regenerative potential by enhancing wound healing, reducing inflammation, and promoting tissue regeneration. However, their clinical translation remains limited and fragmented across study types.
Objective:
To systematically evaluate the efficacy and safety of stem cell-based interventions—including mesenchymal stem cells (MSCs), epidermal stem cells (ESCs), induced pluripotent stem cells (iPSCs), and exosomes—for burn wound healing in preclinical and clinical studies.
Methods:
This review adhered to PRISMA 2020 guidelines. Four databases (PubMed, Embase, Scopus, Cochrane) were searched up to April 27, 2025. Eligible studies included randomized controlled trials and controlled preclinical studies evaluating burn wound healing outcomes with stem cell-based therapies. Risk of bias was assessed using RoB 2 and SYRCLE tools. A random-effects meta-analysis was conducted for compatible outcomes.
Results:
Four studies were included: one clinical trial, two preclinical RCTs, and one narrative review. Stem cell therapies improved wound closure, dermal thickness, angiogenesis, and inflammatory modulation. The meta-analysis of two preclinical studies showed a pooled standardized mean difference (SMD) of 1.15 (95% CI: 0.54 to 1.76), with moderate heterogeneity (I² = 49.4%). GRADE assessments rated the certainty of evidence as moderate for wound healing outcomes and low for safety.

Conclusion:
Stem cell-based interventions, particularly MSCs and exosome-derived products, demonstrate promising regenerative effects in burn wound models. While early-phase clinical findings suggest safety, evidence for efficacy in humans remains limited. Further high-quality trials are needed to support clinical adoption.