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用于临床的马源脱细胞肌腱的最终灭菌

Terminal sterilization of equine-derived decellularized tendons for clinical use.

作者信息

Pellegata Alessandro F, Bottagisio Marta, Boschetti Federica, Ferroni Marco, Bortolin Monica, Drago Lorenzo, Lovati Arianna B

机构信息

Department of Chemistry, Materials and Chemical Engineering Giulio Natta, Politecnico di Milano, Piazza Leonardo da Vinci 32, 20133 Milan, Italy.

Cell and Tissue Engineering Laboratory, IRCCS Galeazzi Orthopaedic Institute, Via Riccardo Galeazzi 4, 20161 Milan, Italy.

出版信息

Mater Sci Eng C Mater Biol Appl. 2017 Jun 1;75:43-49. doi: 10.1016/j.msec.2017.02.009. Epub 2017 Feb 10.

DOI:10.1016/j.msec.2017.02.009
PMID:28415482
Abstract

In the last few years, the demand for tissue substitutes has increased and decellularized matrices has been widely proposed in the medical field to restore severe damages thanks to high biocompatibility and biomechanical properties similar to the native tissues. However, biological grafts represent a potential source of contamination and disease transmission; thus, there is the need to achieve acceptable levels of sterility. Several sterilization methods have been investigated with no consensus on the outcomes in terms of minimizing structural damages and preserving functional features of the decellularized matrix for transplantation in humans. With the aim of making decellularized tendons safe for clinical use, we evaluated the cytocompatibility, and biochemical, structural and biomechanical variations of decellularized equine tendons sterilized with peracetic acid or β-irradiation and differently wet- or dry- stored at 4°C or -80°C, respectively. Considering that both sterilization and long-term storage are crucial steps that could not be avoided, our results pointed at ionizing β-rays as terminal sterilization method for decellularized grafts followed by frozen dry storage. Indeed, this approach can maintain the integrity of collagen-based structures and can avoid biomechanical changes, thus making xenogeneic decellularized tendons a promising candidate for clinical use.

摘要

在过去几年中,对组织替代物的需求不断增加,脱细胞基质因其高生物相容性和与天然组织相似的生物力学特性,在医学领域被广泛用于修复严重损伤。然而,生物移植物是潜在的污染和疾病传播源;因此,需要达到可接受的无菌水平。已经研究了几种灭菌方法,但在将脱细胞基质用于人体移植时,关于如何在最小化结构损伤和保留功能特性方面取得一致的结果尚无定论。为了使脱细胞肌腱能够安全用于临床,我们评估了用过氧乙酸或β射线灭菌,并分别在4°C或-80°C下不同程度湿存或干存的脱细胞马肌腱的细胞相容性、生化、结构和生物力学变化。考虑到灭菌和长期储存都是无法避免的关键步骤,我们的结果表明,电离β射线作为脱细胞移植物的最终灭菌方法,随后进行冷冻干燥储存。事实上,这种方法可以保持基于胶原蛋白结构的完整性,并避免生物力学变化,从而使异种脱细胞肌腱成为临床应用的有希望的候选者。

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