1. Scope 1.1 This document provides guidance on the characterization and evaluation of the decellularization processes used to produce decellularized extracellular matrix xenografts which will be used as implanted medical products. 1.2 This document describes relevant characteristics of decellularization processes used to prepare xenografts as medical devices. 1.3 This document provides guidance on the characterization of specific properties of decellularized xenografts. The focus is on the quantification of cellular material and not on the broader effects of decellularization on tissue properties, such as extracellular matrix composition. 1.4 This document provides guidance on the assessment of the host inflammatory response subsequent to implantation.
- Adequate decellularization is a requirement for implanted xenograft medical products in order to reduce the host tissue inflammatory response and avoid immune rejection.. - Decellularization processes vary in practice, utilizing a variety of chemical agents, temperatures, pressures, and mechanical forces in combinations both simultaneous and in sequence. While any one factor may act through consistent mechanisms, its effect will vary according to the decellularization process in its entirety as well as the particular tissue structure. As such, any evaluation of a decellularization process or a component step therein must be staged within the context of the complete process and the appropriate tissue specimens. -Parallel evaluation of the pre-processed material is recommended for the characterization and evaluation of the efficacy of a decellularization process, but is not necessary as it has no bearing on the host tissue inflammatory response upon implantation. -This guide may be used to evaluate the safety and effectiveness of decellularized xenograft medical devices upon implantation keeping in mind that decellularization is only one factor contributing to safety and efficacy. - This guide may be used to compare alternative decellularization processes for quality control at corporations and by a government agency.
Keywordsdecellularization; extracellular matrix; biomaterials; tissue engineering
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development