The clinical research program described in this report is dedicated to the translation of basic research findings into clinical trials of novel therapies for inflammatory bowel diseases (IBD). In addition, it is structured so as to use basic research methods to define the immune and genetic mechanisms underlying IBD in a variety of settings. This year's research accomplishments include the completion of a protocol studying the safety and efficacy of infusions of a monoclonal antibody to interleukin 17 and the initiation of a bench-to-bedside project with the University of Maryland and Yale University. We screened 3 patients, and enrolled 2 patients into our anti-IL-17 protocol. They finished the protocol successfully without any serious adverse events. Unfortunately, the study was prematurely ended by the sponsor because of a lack of efficacy. We were able to contribute significantly to the study, including sending biopsy samples from our subjects for immunohistochemistry. An abstract was presented at the European Crohn's and Colitis Organization Meeting and a manuscript has been submitted for publication by the study sponsor. We were awarded $140,000 by the Bench-to-Bedside committee to collaborate with the University of Maryland Medical System Department of Gastroenterology and Hepatology to study the mechanisms underlying the response or non-response to anti-TNF therapy. We have successfully started the study with them and are currently enrolling patients. We also have expanded the project to include the Yale Digestive Diseases group. We are currently working on developing new protocols to study the efficacy of a number of new drugs for the treatment of IBD, including the use of mesenchymal stem cells.
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