Overcoming The Challenges Of Developing Microbiome-Based Drugs
Manipulating the human microbiome appears to be an effective approach for treating a range of inflammatory, metabolic, and neurodegenerative diseases, among them inflammatory bowel disease, diabetes, and Parkinson’s disease. Yet the promise of this approach has been hindered by significant barriers in drug development, which manufacturers must strategically address to successfully drive adoption. Current clinical research in microbiome-based therapies focuses mainly on manipulating bacteria in the gut, the most abundant and diverse microbial community in humans, which has a direct impact on metabolism, immunity, and behavior. Probiotic therapies, which involve administering beneficial bacteria to patients to restore healthy microbial function, are so far the most advanced type of microbiome-altering therapy. (Andrew Thomson, Brian Carpenter and Robert Broadnax, 4/16) New England Journal of Medicine:
Warming Up To Cold Perfusion
Each year, thousands of people in the United States die while awaiting lifesaving liver transplantation because there is an insufficient supply of donor organs. This crisis has prompted increased interest in expanding the organ supply through the promotion of both deceased and live liver donation and has led to the encouragement of use of organs from so-called expanded-criteria donation — grafts from older donors, grafts with suboptimal organ quality (e.g., with varying degrees of fatty liver deposits or steatosis), or grafts that had sustained prolonged ischemia times after they were obtained. Livers from deceased donors that are obtained after circulatory death (i.e., DCD [donation after circulatory death] livers) are perhaps the riskiest organs in this category. The challenge in using DCD livers lies in their obligatory exposure to warm ischemia while circulatory death is awaited. The current standard preservation method of ischemic cold storage may lead to profound ischemia–reperfusion injury at the time of transplantation, causing poor outcomes. These may include inferior graft survival and serious short-term complications, the most troublesome of which is ischemic cholangiopathy, which involves scarring of the biliary tree with resultant biliary obstruction and recurrent episodes of cholangitis. Because of these complications, the use of DCD livers is discouraged. Thus, many potentially transplantable organs may be declined; the utilization rate of livers obtained from a donor after circulatory death is only approximately 25%.1 (Winfred W. Williams, M.D., and James F. Markmann, M.D., Ph.D., 4/15)
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