Reports Summarize Type 1 Diabetes Mellitus Findings from Padua University Hospital (First update of the International Xenotransplantation Association…

Reports Summarize Type 1 Diabetes Mellitus Findings from Padua University Hospital (First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in ...)

By a News Reporter-Staff News Editor at Clinical Trials Week -- Current study results on Nutritional and Metabolic Diseases and Conditions - Type 1 Diabetes Mellitus have been published. According to news reporting originating in Padua, Italy, by NewsRx journalists, research stated, "Islet xenotransplantation represents an attractive solution to overcome the shortage of human islets for use in type 1 diabetes. The wide-scale application of clinical islet xenotransplantation, however, requires that such a procedure takes place in a specifically and tightly regulated environment."

The news reporters obtained a quote from the research from Padua University Hospital, "With a view to promoting the safe application of clinical islet xenotransplantation, a few years ago the International Xenotransplantation Association (IXA) published a Consensus Statement that outlined the key ethical and regulatory requirements to be satisfied before the initiation of xenotransplantation studies in diabetic patients. This earlier IXA Statement also documented a disparate regulatory landscape among different geographical areas. This situation clearly fell short of the 2004 World Health Assembly Resolution WHA57.18 that urged Member States 'to cooperate in the formulation of recommendations and guidelines to harmonize global practices' to ensure the highest ethical and regulatory standards on a global scale. In this new IXA report, IXA members who are active in xenotransplantation research in their respective geographic areas herewith briefly describe changes in the regulatory frameworks that have taken place in the intervening period in the various geographic areas or countries. The key reassuring take-home message of the present report is that many countries have embraced the encouragement of the WHO to harmonize the procedures in a more global scale. Indeed, important regulatory changes have taken place or are in progress in several geographic areas that include Europe, Korea, Japan, and China. Such significant regulatory changes encompass the most diverse facets of the clinical application of xenotransplantation and comprise ethical aspects, source animals and product specifications, study supervision, sample archiving, patient follow-up and even insurance coverage in some legislations."

According to the news reporters, the research concluded: "All these measures are expected to provide a better care and protection of recipients of xenotransplants but also a higher safety profile to xenotransplantation procedures with an ultimate net gain in terms of international public health."

For more information on this research see: First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 1: update on national regulatory frameworks pertinent to clinical is. Xenotransplantation, 2016;23(1):14-24. (Wiley-Blackwell - www.wiley.com/; Xenotransplantation - onlinelibrary.wiley.com/journal/10.1111/(ISSN)1399-3089)

Our news correspondents report that additional information may be obtained by contacting E. Cozzi, Dept. of Transfusion Medicine, Transplant Immunology Unit, Padua University Hospital, Padua, Italy. Additional authors for this research include R.R. Tonjes, P. Gianello, L.H. Buhler, G.R. Rayat, S. Matsumoto, C.G. Park, I. Kwon, W. Wang, P. O'Connell, S. Jessamine, R.B. Elliott, T. Kobayashi and B.J Hering (see also Nutritional and Metabolic Diseases and Conditions - Type 1 Diabetes Mellitus).

Keywords for this news article include: Padua, Italy, Europe, Surgery, Bioengineering, Clinical Research, Xenotransplantion, Risk and Prevention, Type 1 Diabetes Mellitus, Clinical Trials and Studies, Insulin Dependent Diabetes Mellitus, Nutritional and Metabolic Diseases and Conditions.

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