Freytes Donald O, Stoner Richard M, Badylak Stephen F
McGowan Institute for Regenerative Medicine, Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pennsylvania 15219, USA.
J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):408-14. doi: 10.1002/jbm.b.30885.
Scaffolds composed of extracellular matrix have been successfully used to support the reconstruction of a variety of tissues in preclinical studies and in clinical applications. As an off-the-shelf product, extracellular matrix (ECM) scaffolds must be subjected to terminal sterilization before use. The choice of sterilization method may alter the integrity of the ECM's composition and structure such that the mechanical and material properties are adversely affected. The present study evaluated selected structural properties of an ECM scaffold derived from the urinary bladder termed urinary bladder matrix after being sterilized by three different methods: ethylene oxide (ETO) (750 mg/h for 16 h), gamma irradiation (2.0 Mrads), or electron beam irradiation (e-beam) (2.2 Mrads). The structural properties that were evaluated include maximum force, maximum elongation, maximum tangential stiffness, energy dissipation, and ball-burst strength. All sterilization methods affected at least two of the measured properties. ETO was shown to have the least detrimental effect upon the measured properties. Gamma and e-beam irradiation were shown to decrease the uniaxial and biaxial strength, maximum tangential stiffness, and the energy dissipation of the ECM scaffolds. The present study showed that the choice of terminal sterilization method affects the structural properties of scaffolds composed of extracellular matrix.
在临床前研究和临床应用中,由细胞外基质组成的支架已成功用于支持多种组织的重建。作为一种现成的产品,细胞外基质(ECM)支架在使用前必须进行终端灭菌。灭菌方法的选择可能会改变ECM的组成和结构的完整性,从而对其机械和材料性能产生不利影响。本研究评估了一种源自膀胱的ECM支架(称为膀胱基质)在通过三种不同方法灭菌后的选定结构特性:环氧乙烷(ETO)(750 mg/h,持续16小时)、伽马射线辐照(2.0兆拉德)或电子束辐照(电子束)(2.2兆拉德)。所评估的结构特性包括最大力、最大伸长率、最大切向刚度、能量耗散和球囊破裂强度。所有灭菌方法均至少影响了两项测量特性。结果表明,ETO对测量特性的不利影响最小。伽马射线和电子束辐照均会降低ECM支架的单轴和双轴强度、最大切向刚度以及能量耗散。本研究表明,终端灭菌方法的选择会影响由细胞外基质组成的支架的结构特性。