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)