van Hengel Elena V A, van der Laan Luc J W, de Jonge Jeroen, Verstegen Monique M A
Department of Surgery, Erasmus MC Transplant Institute, University Medical Center Rotterdam, 3015 GD Rotterdam, The Netherlands.
Bioengineering (Basel). 2025 Jan 30;12(2):136. doi: 10.3390/bioengineering12020136.
Whole-organ decellularization generates scaffolds containing native extracellular matrix (ECM) components with preserved tissue microarchitecture, providing a promising advancement in tissue engineering and regenerative medicine. Decellularization retains the ECM integrity which is important for supporting cell attachment, growth, differentiation, and biological function. Although there are consensus guidelines to standardize decellularization processes and ECM characterization, no specific criteria or standards regarding matrix sterility and biosafety have been established so far. This regulatory gap in safety, sterilization, and regulation criteria has hampered the clinical translation of decellularized scaffolds. In this review, we identify essential criteria for the safe clinical use of decellularized products from both human and animal sources. These include the decellularization efficacy, levels of chemical residue, preservation of ECM composition and physical characteristics, and criteria for the aseptic processing of decellularization to assure sterility. Furthermore, we explore key considerations for advancing decellularized scaffolds into clinical practice, focusing on regulatory frameworks and safety requirements. Addressing these challenges is crucial for minimizing risks of adverse reactions or infection transmission, thereby accelerating the adoption of tissue-engineered products. This review aims to provide a foundation for establishing robust guidelines, supporting the safe and effective integration of decellularized scaffolds into regenerative medicine applications.
全器官去细胞化可生成含有天然细胞外基质（ECM）成分且保留组织微结构的支架，为组织工程和再生医学带来了有前景的进展。去细胞化保留了ECM的完整性，这对于支持细胞附着、生长、分化及生物学功能至关重要。尽管已有共识指南来规范去细胞化过程和ECM表征，但目前尚未建立关于基质无菌性和生物安全性的具体标准或规范。安全、灭菌和监管标准方面的这一监管空白阻碍了去细胞化支架的临床转化。在本综述中，我们确定了来自人类和动物源的去细胞化产品安全临床应用的基本标准。这些标准包括去细胞化效果、化学残留水平、ECM组成和物理特性的保留情况，以及去细胞化无菌处理以确保无菌的标准。此外，我们探讨了将去细胞化支架推进到临床实践中的关键考虑因素，重点关注监管框架和安全要求。应对这些挑战对于将不良反应或感染传播风险降至最低至关重要，从而加速组织工程产品的应用。本综述旨在为建立强有力的指南提供基础，支持将去细胞化支架安全有效地整合到再生医学应用中。
