The Importance of Sex-Based Comparisons in Preclinical Nanomedicine and Regenerative Chronic Wound Therapies

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)

It is increasingly recognized that immune responses, plasma proteomes, and various biosystem reactions to advanced therapeutics, such as nanomedicine and regenerative medicine, differ by gender. While sex is a crucial factor influencing the safety and efficacy of these therapies, there is a notable lack of robust consideration of sex differences in both preclinical and clinical studies. This Perspective examines the current literature on the role of sex in nanomedicine and biomaterial-based products for preclinical chronic wound healing. While there is a growing trend of using both male and female animal models, most studies lack direct, side-by-side comparisons of sex-specific outcomes. Specifically, 77.8% of nanomedicine and 85.3% of biomaterial studies exclusively employed either male or female animals. Only 7.4% of nanomedicine and 2.1% of biomaterials publications included both sexes; however, apart from two studies, most did not perform direct sex-based comparisons. Instead, they often assigned different sexes to separate species, wound types, or experimental conditions (e.g., noninfected versus infected wounds). To deepen our understanding of sex differences in advanced therapeutics, future research should focus on direct, side-by-side comparisons of male and female in vivo models for safety and efficacy.

Evidence level

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

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