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: