INTRA-LUMENAL ROBOT FOR MINIMALLY-INVASIVE GI PROCEDURES

DESCRIPTION (Verbatim from the Applicant's Abstract): This Phase I SBIR application seeks support to develop and evaluate the use of an extracellular matrix (ECM) bioscaffold derived from the urinary bladder-extracellular matrix (UBM) for the repair and reconstruction of diseased esophageal tissue. Porcine-derived UBM represents an acellular biodegradable scaffold material that supports cell attachment, migration, proliferation, differentiation, and tissue remodeling. The hydrated form of single sheets of UBM and other ECMs have shown excellent remodeling capabilities in both preclinical animal studies and human clinical studies for applications unrelated to the gastrointestinal tract. We propose to conduct three studies. Study #1 will establish manufacturing methods for a multilaminate sheet of UBM that has defined mechanical properties sufficient for esophageal repair. Study #2 will evaluate the ability of a multilaminate UBM sheet to support primary esophageal epithelial cell growth in vitro. Study #3 will utilize the prototype multilaminate UBM device in a preliminary dog study in which a full circumference segmental esophageal defect will be repaired. Currently, there are no viable options for a biomaterial to replace esophageal tissue. Esophageal stricture, and lack of esophageal motility are serious limitations to existing biomaterial alternatives for this application. As location of autologous stomach or bowel account for a majority of existing surgical techniques for the repair or reconstruction of segments of the esophagus at the present time. Successful completion of the three specific aims defined for this Phase I project will provide the necessary information to decide whether or not this UBM scaffold should be evaluated further as a biomaterial for esophageal repair. Each objective/specific aim has well-defined endpoints and criteria for success. An experienced and knowledgeable research team will conduct the proposed studies and time line for the proposed work is provided. This technology provides an innovative tissue engineering approach in a medical field with significant unmet needs. PROPOSED COMMERCIAL APPLICATION: 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 tissue 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 with virtually no biomaterial options, the successful completion of this SBIR application addresses a significant unmet clinical need.