We will establish a working group of industry stakeholders to develop a robust protocol for measuring cell viability in a tissue engineering scaffold. We will use discussions among the working group to select an appropriate test system including the assay, scaffold and cell type. We aim to select a scaffold system that can be disassembled to release the cells. In this way, we can compare assays conducted on scaffolds containing cells to results on the released cells. We also aim to use a higher order measurement to verify results, such as electron paramagnetic resonance to assess partial oxygen pressure in the scaffold. We will assess reproducibility of the test method through an inter-laboratory test. We will use the results of these studies to support an ASTM standard test method.
Keywordstissue engineering; scaffold; cell viability
The standard is needed by the tissue engineering industry. It has become widely acknowledged that the inability to adequately assess cell viability in a scaffold is a major impediment to the growth of the tissue engineering industry. Typically, metabolic assays that have been developed for cells cultured on planar substrates, such as tissue culture polystyrene, are used to assess cells in 3D scaffolds. There are two issues to this approach. First, the scaffold may impede the diffusion of assay reactants and products into and out of the scaffold, yielding inaccurate results. Second, there are many sample handling issues that arise from seeding cells onto scaffolds or conducting assays on cells in scaffolds that affect the measurement uncertainty in unknown ways.
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development