New Guide for Classifying Extracellular Matrices for Use as Tissue Engineered Medical Products
1. Scope
This standard intends to serve as a foundational document for individuals and organizations involved in the development, production, delivery, and regulation of extracellular matrices (ECMs) used in tissue engineered medical products (TEMPs). This standard is limited to ECMs that are cell-derived acellular tissue products that have intentional preservation of chemical and/or structural composition and that are the end product or part of a final product for use as a therapy. This standard will provide nomenclature that allows for tiered categorization of ECMs based on source material origin, synthesis, tissue type, and post processing characteristics. Additionally, high level information for different categories of product will be provided; this includes product risks (e.g. immunogenicity), common miscommunications, assays used to test performance and quality, and regulatory considerations.
This standard is intended to be used to facilitate communication and agreement on basic principles by those working with ECMs in TEMPs, such as manufacturers, researchers, and end users. This can be used as the groundwork for future standards on specific ECM types used in TEMPs. This standard is written primarily for human use, however the general concepts, classifications, and considerations apply to veterinary medicine.
ECMs that have been isolated, fragmented, or comminuted are within scope of this document. However, ceramic ECMs, blood products, synthetic ECM mimics, recombinant proteins, purified/fractionated proteins, and ECMs used purely as agents of expression or as diagnostic tools are out of scope of this document.
Keywords
ECM; TEMP; acellular
Rationale
The goal of this task is to develop categorization for ECM medical products which will provide a common framework for understanding the applicable risks and characteristics inherent in the products. The standardized categorization will also support the tasks of creating subsequent standards for ECM/tissue products with narrower scopes defined through the categorization.
