Tissue engineering has emerged as a promising avenue for reconstructive urology, though only a limited number of tissue‐engineered urethral constructs have advanced to clinical testing. Presently, there exists a dearth of agreement regarding the most promising constructs deserving of implementation in clinical practice. The objective of this review was to provide a comprehensive analysis of preclinical trials findings of a tissue‐engineered urethra and to identify the most promising constructs for future translation into clinical practice. A systematic search of the Pubmed, Scopus, and PMC databases was conducted in accordance with the PRISMA statement. Manuscripts published in English between 2015 and 2022, reporting on the methodology for creating a tissue‐engineered urethra, assessing the regenerative potential of the scaffold in a male animal model, and evaluating the clinical and histological outcomes of treatment, were included. A total of 48 manuscripts met the inclusion criteria, with 12 being eligible for meta‐analysis. Meta‐analysis revealed no significant benefit of any matrix type in terms of complication rates. However, acellular matrices demonstrated significant advantage over cellular matrices in case of no postoperative stricture formation (odds ratio = 0.06 [95% CI 0.01; 0.23], p < 0.01). Among all subgroups (animal models and scaffold types), the usage of acellular matrices resulted in advantageous effects. The meta‐regression analysis did not show a significant impact of defect length (β1 = −0.02 [−0.28; 0.23], p = 0.86). We found that decellularized materials may carry less relevance for urethral reconstruction due to unfavorable preclinical outcomes. Natural polymers, used independently or with synthetic materials, resulted in better postoperative outcomes in animals compared to purely synthetic constructs. Acellular scaffolds showed promising outcomes, matching or exceeding cellular constructs. However, more studies are needed to confirm their clinical effectiveness.

中文翻译：

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基于雄性动物临床前试验寻找用于临床应用的最佳组织工程尿道模型：系统评价和荟萃分析


组织工程已成为重建泌尿外科的一条有前途的途径，尽管只有有限数量的组织工程尿道结构已进入临床试验。目前，对于值得在临床实践中实施的最有前途的结构，缺乏共识。本综述的目的是对组织工程尿道的临床前试验结果进行全面分析，并确定未来转化为临床实践的最有前途的结构。根据 PRISMA 声明对 Pubmed、Scopus 和 PMC 数据库进行了系统检索。包括 2015 年至 2022 年间以英文发表的手稿，报告了创建组织工程尿道的方法，评估了雄性动物模型中支架的再生潜力，并评估了治疗的临床和组织学结果。共有 48 篇手稿符合纳入标准，其中 12 篇符合荟萃分析条件。Meta 分析显示，就并发症发生率而言，任何基质类型均无显著获益。然而，在术后没有狭窄形成的情况下，无细胞基质比细胞基质具有显著优势（比值比 = 0.06 [95% CI 0.01;0.23]，p < 0.01）。在所有亚组 （动物模型和支架类型） 中，使用脱细胞基质产生了有利的效果。meta 回归分析未显示缺陷长度的显着影响 （β1 = -0.02 [-0.28;0.23]，p = 0.86）。我们发现，由于临床前结果不佳，脱细胞材料与尿道重建的相关性可能较低。 与纯合成结构相比，单独使用或与合成材料一起使用的天然聚合物可使动物的术后结局更好。无细胞支架显示出有希望的结果，匹配或超过细胞构建体。然而，需要更多的研究来证实其临床有效性。