News

Consensus Statement on Conditions for Undertaking Clinical Islet Xenotransplantation Trials

In 2008, the IXA Council and TTS executive committee unanimously endorsed Interim Recommendations for Preclinical Data to support Clinical Islet Xenotransplantation. (Interim Recommendations for Preclinical Data to support Clinical Islet Xenotransplantation). On July 27, 2009 the IXA, in concert with The Transplantation Society, published a draft definitive Consensus Statement describing our detailed recommendations regarding safe, scientifical and ethically reasonable conditions that should be met in order to undertake a clinical islet xenotransplantation trial. We have worked closely with WHO and various national regulatory bodies during the past two years to help craft these consensus guidelines. The resulting document, representing the work of many members of our association, was primarily authored by Bernhard Hering and an IXA writing committee, and will be published this fall in Xenotransplantation. Public comments received at [you supply target email or web-based submission form] by August 7 will be considered by the authors as they finalize the document. In addition, at the discretion of the respondent, related correspondence posted at the above address will be considered for publication by Xenotransplantation's editor. Relevant recent publications and key regulatory documents related to xenotransplantation are available through the following links: WHO – Xenotransplantation Advisory Consultation Report (Geneva – April 2005) Informed Consent In Clinical Research Involving Xenotransplantation (June 2004) WHA57.18 – 57th World Health Assembly (May 2004) Guidance for Industry – Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans (April 2003) PHS Guideline on Infectious Disease Issues in Xenotransplantation (January 2001) Position Paper of the Ethics Committee of IXA (December 2002) Report of WHO Consultation on Xenotransplantation (Geneva, Switzerland – October 1997)

Read more: Islet Recommendations

Current Initiatives

Under the able leadership of Ian McKenzie, Tony D’Apice and Megan Sykes, and in concert with TTS and WHO, IXA has promoted ethical and regulatory guidelines for clinical xenotransplantation trials for consideration by national regulatory authorities. The association has three important goals for the coming years: to facilitate implementation of internationally consistent national regulations for the conduct of clinical xenotransplant trials. to promote conduct of ethical clinical trials that are safe for the participants, minimize health risks for the public at large, and are likely to promote future success. Such trials should be based, to the greatest extent possible, on preclinical observations in nonhuman primate models that unequivocally indicate that efficacy is likely. to educate citizens around the world about the benefits, risks, and scientific hurdles to achieving the vast therapeutic potential of cross-species transplantation.

Read more: IXA Updates

IXA Information Exchange Meeting with the FDA

Dear Members, The International Xenotransplantation Association (IXA) Council will be holding an information exchange meeting with representatives of the Federal Drug Administration (FDA) during the upcoming American Transplant Congress in Boston in June 2016. The purpose of the meeting is to update the FDA on the latest developments in xenotransplantation and to learn about the FDA approval procedure for xenotransplantation clinical trials, followed by a discussion to convey the key issues to the FDA including the possibility of modifying the current guidelines. We would like to ensure that members have their say in this process, so we ask that if you have any specific questions or suggestions for changes to the guidelines (attached), please send them to IXA Secretariat at This email address is being protected from spambots. You need JavaScript enabled to view it. by April 30, 2016. Sincerely, Peter Cowan IXA President Muhammad Mohiuddin IXA Communications Taskforce Chair

FDA CVM Guidance for Industry #187 (2009, updated 2015)

FDA Guidance for Xenotransplantation Products (2003)

Member Login

More Articles ...

Social

Contact

Address

Info