Project: Standard Guide for Characteristics of Extracellular Matrices for Use as Tissue Engineered Medical Products
Type: STANDARDS ADVANCEMENT PROJECT
Partners: ASTM F04 AND THE SCB Tissue EngineerING SECTOR WORKING GROUP
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Description:
The frequency of use of ECM products has gradually increased, as has the range of available products and applications as well as the opportunity for variable patient outcomes across these factors. Patient outcomes may be affected by multiple attributes, both related to a product’s ECM source and the processing used to create the end product. A standardized categorization of these attributes can guide producers in best practices within any subset and aid in the comparison of similar products.
In addition, standardized terminology and categorization of products harmonized with end user medical terminology would substantially improve communication between stakeholders and avoid confusion.
While ECM medical products comprise a subset of TEMPs, the cell or tissue source of the material, and processing steps can vary substantially. As a result it is difficult to compare products or make reliable recommendations with respect to biological or chemical risks, or quantitative characterization of chemical composition or microstructural organization.
The goal of this SCB Working Group is to provide a guide for characteristics of ECM medical products which will provide a high level framework for understanding these characteristics, risks, and applications that are inherent in these products. The standardized characteristic descriptions will support the tasks of creating subsequent standards for ECM/tissue products with narrower scopes.
Anticipated Availability: 2026
Progress:
(learn more about the standards advancement process)
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary
Assembled a Biological Evaluation of Tissues and Extracellular Matrices Used in Tissue Engineering Working Group: SCB has established a working group for this effort and initiated a monthly working group meetings to coordinate the standard advancement effort.
Conducted Feasibility Assessment: In June 2022, SCB organized a meeting of 27 experts from multiple stakeholder groups to discuss barriers and opportunities for potential Biological Evaluation of Tissues and Extracellular Matrices Used in Tissue Engineering for In Vivo Studies standard topics. SCB developed a feasibility report on the assessment outcomes and planned next steps.
Begin Drafting Standard: SCB presented the standard to ASTM in May 2023. SCB will coordinate the working group as it drafts the standard.
Get Engaged:
To join the working group or learn more about this initiative, please compete this survey or contact SCB