Clincal experience with an ECM scaffold for tissue engineering

Summary form only given. Porcine-derived, xenogeneic extracellular matrix (ECM) has been used as a scaffold for several tissue engineering applications in more than 100,000 human patients during the past two years. This xenogeneic ECM is derived from the small intestinal submucosa (SIS) of pigs. This ECM has been shown to contain numerous growth factors including vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), transforming growth factor beta (TGF beta), and a naturally occurring mixture of glycosaminoglycans, proteoglycans, and several types of structural collagen. These functional and structural proteins are arranged in a unique ultrastructure that supports constructive tissue remodeling. Clinical applications in humans have included repair of chronic, full-thickness skin wounds, lower urinary tract reconstruction, gastrointestinal tract repair, replacement of the dura mater, repair and replacement of numerous musculoskeletal soft tissue structures including the rotator cuff, Achilles tendon, and ligamentous structures, and arterial vascular repair, among others. Common features of ECM remodeling include rapid and complete scaffold degradation (within 2-3 months) and population of the scaffold by host-derived, site appropriate mesenchymal and epithelial cells. A review of the clinical experience, including the immunologic response of the patients to this xenogeneic scaffold, will be presented.