Regulation of Clinical Xenotransplantation-Time for a Reappraisal.

Transplantation

1 Thomas E Starzl Transplantation Institute, Department of Surgery, University of Pittsburgh, Pittsburgh, PA. 2 Division of Cardiac Surgery, Department of Surgery, University of Maryland, Baltimore VAMC, Baltimore, MD. 3 Schulze Diabetes Institute, Department of Surgery, University of Minnesota, Minneapolis, MN. 4 National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD. 5 MGH Transplantation Center and Transplant Infectious Disease and Compromised Host Program, Massachusetts General Hospital/Harvard Medical School, Boston, MA. 6 Robert Koch Institute, Berlin, Germany. 7 Transplantation Research Institute, College of Medicine, Seoul National University, Seoul, South Korea. 8 Department of Surgery, University Hospital Geneva, Geneva, Switzerland. 9 Immunology Research Center, St Vincent's Hospital Melbourne, University of Melbourne, Melbourne, Victoria, Australia. 10 Department of Surgery, Westmead Clinical School, University of Sydney, Westmead Hospital, Westmead, New South Wales, Australia. 11 Department of Renal Transplant Surgery, Aichi Medical University School of Medicine, Nagakute, Japan. 12 Columbia University Medical Center, New York, NY.

Published: August 2017

The continual critical shortage of organs and cells from deceased human donors has stimulated research in the field of cross-species transplantation (xenotransplantation), with the pig selected as the most suitable potential source of organs. Since the US Food and Drug Administration concluded a comprehensive review of xenotransplantation in 2003, considerable progress has been made in the experimental laboratory to improve cell and organ xenograft survival in several pig-to-nonhuman primate systems that offer the best available models to predict clinical outcomes. Survival of heart, kidney, and islet grafts in nonhuman primates is now being measured in months or even years. The potential risks associated with xenotransplantation, for example, the transfer of an infectious microorganism, that were highlighted in the 2003 Food and Drug Administration guidance and subsequent World Health Organization consensus documents have been carefully studied and shown to be either less likely than previously thought or readily manageable by donor selection or recipient management strategies. In this context, we suggest that the national regulatory authorities worldwide should re-examine their guidelines and regulations regarding xenotransplantation, so as to better enable design and conduct of safe and informative clinical trials of cell and organ xenotransplantation when and as supported by the preclinical data. We identify specific topics that we suggest require reconsideration.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5702547PMC
http://dx.doi.org/10.1097/TP.0000000000001683DOI Listing

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