New Guide for Ontology of Extracellular Matrices for Use as Tissue Engineered Medical Products
1. Scope
1.1. 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) and related tissue products used in tissue engineered medical products (TEMPs).
1.2. This standard provides nomenclature that allows for groupings and differentiation of ECMs based on tissue source or cell origin, 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, and tests of performance and quality.
1.3. 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, regulators, 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, categorization, and considerations may apply to veterinary medicine.
1.4. This standard is intended for ECMs that are cell-derived tissue products and that are not fractionated to change the biologically relevant chemical composition or microarchitecture of the tissue. ECMs that have been isolated, cleaned, fragmented, or comminuted are within scope of this document. Several prominent examples of ECMs covered by this standard include decellularized extracellular matrix, demineralized bone matrix, and devitalized allografts. However, blood products, synthetic ECM mimics (electrospun polymer fiber mats), recombinant proteins, purified/fractionated proteins, and diagnostic tools are out of scope of this document. This standard is not intended to aid in characterizing or comparing live cells.
1.5. Safety and validation associated with the use of ECMs are not comprehensively addressed in this standard. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7. This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of international Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Keywords
acellular; decellularized
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.
