Grafts are required to restore tissue integrity and function. However, current gold standard autografting techniques yield limited harvest, with high rates of complication. In the search for viable substitutes, the number of biomaterials being developed and studied has increased rapidly. To date, low clinical uptake has accompanied inherently high failure rates, with immune rejection a specific and common end result. The objective of this review article was to evaluate published immune assays evaluating biomaterials, and to stress the value that incorporating immune assessment into evaluations carries. Immunogenicity assays have had three areas of focus: cell viability, maturation and activation, with the latter being the focus in the majority of the literature due to its relevance to functional outcomes. With recent studies suggesting poor correlation between current in vitro and in vivo testing of biomaterials, in vitro immune response assays may be more relevant and enhance ability in predicting acceptance prior to in vivo application. Uptake of in vitro immune response assessment will allow for substantial reductions in experimental time and resources, including unnecessary and unethical animal use, with a simultaneous decrease in inappropriate biomaterials reaching clinic. This improvement in bench to bedside safety is paramount to reduce patient harm.
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