ACell is a tissue engineering company and its core technology is based upon a porcine derived extracellular matrix (ECM) harvested from the urinary bladder (UBM) that serves as a constructive scaffold for tissue reconstruction. Successful completion of Phase I studies showed that the UBM-ECM can be configured into a tube shaped device with mechanical and material properties suitable for the repair of esophageal tissue. These studies also showed that primary canine esophageal epithelial cells could attach, proliferate and differentiate in vitro upon the UBM scaffold. Finally, a preliminary study in a dog model demonstrated the ability of the resorbable UBM scaffold to replace native esophageal tissue with host derived tissues that included an intact squamous epithelium, submucosal vascularized collagenous tissue and subjacent bundles of skeletal muscle appropriate for the resected segment of cervical esophagus. The present Phase II SBIR proposal seeks support to pursue the development of the UBM bioscaffold as a device for the repair or replacement of damaged or missing esophageal tissue; a surgical application that currently has very limited options. There are three studies described, each of which addresses a clearly defined specific aim: (1) to determine the fate and mode of degradation of the porcine derived UBM scaffold when used as an esophageal repair device in a dog model; (2) to complete ISO-9001 testing as a prerequisite to regulatory submission of an Investigational Device Exemption (DE); and (3) to examine the safety and efficacy of the UBM device in a definitive chronic study using an animal model. The work will be conducted by an experienced interdisciplinary group of investigators and will combine the expertise of ACell's professional staff, the certified laboratories of the North America Science Associates (NamSA), and a university partner. A timeline for completion of the studies, clearly defined criteria for success, and plans for subsequent Phase III work are included in this Phase II proposal.
Congenital and acquired abnormalities of the esophagus present surgical challenges with extremely limited options. Morbidity associated with surgical procedures is significant. Stricture of the esophagus following either injury or replacement of damaged tissues by existing biomaterials is a significant problem. Esophageal adenocarcinoma has increased in incidence by 350% since the mid-1970's. Since this is a clinical area withe virtually no biomaterial options, the successful completion of this SBIR application addresses a significant unmet clinical need.