Mar 16, 2012

The host response to endotoxin-contaminated dermal matrix

Tissue Engineering. Part a
K A DalyStephen F Badylak

Abstract

Biologic scaffold materials composed of extracellular matrix (ECM) have been shown to promote the formation of site-specific, functional, host tissue following placement in a number of preclinical and clinical studies. Endotoxin contamination of biomaterials is thought to result in deleterious immune responses that may affect the remodeling outcome when present in significant quantities. However, the exact amount of endotoxin contamination within or upon an ECM-based biologic scaffold that is required to elicit adverse effects in recipients is currently unknown. The present study examined the in vitro and in vivo effects of endotoxin contamination within an ECM scaffold derived from porcine dermis upon the host immune response and the downstream ability of the scaffold material to promote constructive tissue remodeling. Test articles with endotoxin values that exceed the current U.S. Food and Drug Administration (FDA) limit had similar or decreased immune responses both in vitro and in vivo when compared with devices that were below the current FDA limit. Dermal matrices spiked with large doses of endotoxin (100 ng/mL), equivalent to 10-20 times the FDA limit, elicited a robust immune response in vitro. However, by 35 days post...Continue Reading

Mentioned in this Paper

Immune Response
Tlr4 protein, rat
Tumor Necrosis Factor-alpha
Toll-like receptor 4
Dermis
Extracellular Matrix
Monocyte Chemoattractant Protein-1
Adverse Effects
Cell Proliferation
Sus scrofa domestica

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