NANOFIBER SOLUTIONS LLC — Department of Health and Human Services SBIR Phase I: 300

Description

DESCRIPTION provided by applicant Short bowel syndrome SBS a major clinical problem affecting patients of all ages results from the functional or anatomic loss of extensive segments of small intestine SBS has an overall year survival of and in newborn infants with less than of expected intestinal length year survival is only Current treatment options are inadequate and associated with severe complications and death Patients with SBS require total parenteral nutrition TPN to survive Currently over SBS patients per year are on home TPN in the US alone Annual costs of home TPN exceed $ per year per patient $ billion year In addition the use of TPN is associated with numerous central venous catheter associated infectious and thrombotic complications resulting in additional high costs Thus SBS represents an extremely costly and deadly burden to society At present the treatment for SBS is mainly supportive Although small bowel transplantation is an option the results are suboptimal with year and year survival rates of and respectively and the required life long immunosuppression causes substantial secondary complications Novel approaches for the treatment of patients with SBS are critically needed Our approach to this unsolved medical problem is the production of tissue engineered intestine TEI using the patientandapos s own intestinal cells combined with a synthetic nanofiber based scaffold resulting in a novel solution to this unmet clinical need In this project we will accomplish three specific aims necessary to move towards commercialization Aim Determine the optimal cell isolation and cell seeding methodology for structural formation of TEI Aim Optimize enteric nervous system ENS development in TEI Aim Develop an in vivo culture standard operating procedure SOP for development of TEI This Phase I SBIR project will allow us to collect the pivotal data needed to scale up to a large animal model in Phase II and to license the technology to a commercial partner in Phase III for commercialization PUBLIC HEALTH RELEVANCE In this work we will develop robust and healthy tissue engineered intestine using nanofiber scaffolds combined with intestinal stem cells for patients suffering from short bowel syndrome SBS Our initial clinical indication is necrotizing enterocolitis NEC which affects premature babies and has a mortality rate of nearly