Beyond wound closure: translational opportunities and barriers of mesenchymal stem cells and their extracellular vesicles in burn management

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Burn injury management continues to present multiple clinical challenges, including infection, scar formation, and functional restoration. Mesenchymal stem cells (MSCs) and their secretome (exosomes) have emerged as a cell-free therapy with multitarget potential in inflammation regulation, angiogenesis, epithelial regeneration, and extracellular matrix (ECM) remodeling. Rather than classifying by cell origin, this review is guided by clinical needs and translational pathways to propose a framework for productization and translational development. MSC/EVs strategies exhibit unique advantages along the inflammation-regeneration-fibrosis axis, making them suitable for integration into dressings, delivery systems, and combination therapies. Current obstacles include donor and source consistency, Good Manufacturing Practice (GMP) compliance, standardization of Critical Quality Attributes (CQAs), optimization of administration strategies, and selection of clinically meaningful endpoints. Establishing standardized production and quality-control systems, along with promoting multicenter randomized studies, is essential to achieve high-quality translation from research to clinical practice.

Evidence level

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

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