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Columbus, OH, United States

Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 255.93K | Year: 2011

This Small Business Technology Transfer Research (STTR) Phase II project is for the development of an inexpensive, rapid, high-accuracy test for the detection and identification of the pathogens that cause urinary tract infections (UTIs). Currently, UTI diagnosis is an expensive and lengthy process that often results in patients given unnecessary or ineffective antibiotics. This pathogen detection system utilizes highly dispersible polyaniline nanofibers that bind to markers in urine to generate a visible change in solution with the appearance of nanofiber aggregates. Versions of this test will be optimized for UTI detection, leukocyte detection and pathogen identification. An array of nanofibers functionalized for detection of different bacterial markers will be used for demonstration of pathogen identification.

The broader impacts of this research are increased access to accurate tests for pathogen identification, healthcare cost reduction and reduction of antibiotic resistance. The low cost and ease of this test will allow patients to get diagnosed expeditiously, and then treated properly using species-directed medication rather than broad antibiotic coverage. This will have a great impact on decelerating the rise of antibiotic resistance. This test also has potential with future development in other target detection applications such as food/water testing and meningitis. Researchers may also benefit from this development as an alternative to more expensive and slower routes for identification of pathogens like culture. The overall cost reduction associated with this method of marker detection may also increase access to better infection diagnosis and treatment to lower income populations and patients in third world countries.

Research Institute At Nationwide Childrens Hospital Inc. and Nanofiber Solutions | Date: 2014-03-14

The invention provides for engineered intestinal construct and methods of making these constructs. The invention also provides for methods of treating short bowel syndrome or methods of repairing an intestine after resection comprising inserting an engineered intestinal construct into the intestine of a subject in need.

Nanofiber Solutions | Date: 2014-03-17

A biocompatible textile and methods for its use and fabrication are disclosed. The textile may be fabricated from electrospun fibers forming windings on a mandrel, in which the windings form openings having a mesh size between adjacent windings. The textile may also be fabricated by the addition of solvent-soluble particles incorporated into the textile while the windings are formed. Such particles may be removed by exposing the textile to a solvent, thereby dissolving them. Disclosed are also replacements for animal organs composed of material including at least one layer of an electrospun fiber textile having a mesh size. Such replacements for animal organs may include biocompatible textiles treated with a surface treatment process.

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 250.00K | Year: 2015

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

Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 624.63K | Year: 2015

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is focused on developing a customizable tissue engineered tracheal implant for tracheal transplantation and reconstruction surgery. Current surgical solutions for these patients are limited by problems with the availability of suitable cadaveric tissue, as well as with unsatisfactory long-term survival of the engrafted tissues due to issues with both revascularization and immune rejection. The combination of an inert biomaterial scaffold and autologous cells avoids any concerns with graft rejection, while allowing for the reliable production of tracheal grafts. Nanofiber Solutions expects this new device will enable as many as 6,500 life-saving procedures annually. A successful Phase 2 project will demonstrate long-term performance of the nanofiber tracheal implant and the mechanisms of action in a large animal model as well as a humanitarian device exemption (HDE) application with the FDA to initiate a clinical trial. This trachea implant product addresses a $600 million dollar opportunity. Other tissue engineered products based on this technology platform address billions of dollars more in market opportunity. The proposed project is focused on developing a customizable tissue engineered tracheal implant for tracheal transplantation and reconstruction surgery. The trachea has challenging mechanical and biological requirements, and despite many attempts there currently is no fully functional artificial trachea. The fully synthetic tracheal scaffold is seeded with autologous stem cells harvested from the patient?s bone marrow. To prepare for an FDA submission and initial human clinical trials, we will accomplish three technical objectives in this Phase II work: 1) Optimize the use of a closed system, disposable seeding chamber to allow uniform cell seeding throughout the scaffold, 2) Develop a commercial manufacturing process for the production and placement of support ribs on the tracheal graft, and 3) Elucidate mechanisms of tracheal regeneration in vivo of intraoperatively seeded tracheal implants.

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