Xenogeneic extracellular matrix as a scaffold for tissue reconstruction

Bioscaffolds derived from xenogeneic extracellular matrix (ECM) have been used in numerous tissue engineering applications. The safety and efficacy of such scaffolds when used for the repair and reconstruction of numerous body tissues including musculoskeletal, cardiovascular, urogenital and integumentary structures has been shown in both preclinical animal studies and in human clinical studies. More than 200,000 human patients have been implanted with xenogeneic ECM scaffolds. These ECM scaffolds are typically prepared from porcine organs such as small intestine or urinary bladder, which are subjected to decellularization and terminal sterilization without significant loss of the biologic effects of the ECM. The composition of these bioscaffolds includes the structural and functional proteins that are part of native mammalian extracellular matrix. The three-dimensional organization of these molecules distinguishes ECM scaffolds from synthetic scaffold materials and is associated with constructive tissue remodeling instead of scar tissue. The biologic response to these xenogeneic bioscaffolds, including the immune response, is discussed herein.