Regulatory Documents and Guidelines

Activities and resources research
Veterinary Resources
Some information about reagents reactive with pig or primate species is available through the following links:

Protocols and Published Methods
Anti-nonGal antibody assays

PERV assays

Coagulation assays

Swine Centers
The National Swine Resource and Research Center (NSRRC) was established in 2003 to develop the infrastructure to ensure that biomedical investigators across a variety of disciplines have access to critically needed swine models of human health and disease. The NSRRC will also serve as a central resource for reagents, creation of new genetically modified swine, and information and training related to use of swine models in biomedical research.

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Clinical Activities
Current Initiatives
In concert with TTS and WHO, IXA has the mission to promote ethical and regulatory guidelines for xenotransplantation clinical trials for consideration by national regulatory authorities. IXA has three important goals:
  1. To facilitate implementation of internationally consistent national regulations for the conduct of xenotransplant clinical trials.

  2. 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.

  3. To educate people around the world about the benefits, risks, and scientific hurdles to achieving the vast therapeutic potential of cross-species transplantation.


Clinical Xenotransplant Registry
The World Health Organization (WHO) is actively encouraging national health authorities to contribute information on the clinical xenotransplantation activities that are taking place in their countries. In parallel, reports from IXA members or any person aware of such practices may be a complementary source of information for this international inventory of xenotransplantation practices in humans. The information will ultimately be used to inform national health authorities, health care staff, and the public. The registry’s objective is to encouraging good xenotransplantation practices under internationally harmonized, consistent guidelines and regulation.

We remind our membership to please register any clinical xenotransplantation activities that they have conducted in the past, or may otherwise be aware of, through the WHO Geneva website, at www.humanxenotransplant.org
Guidelines for Clinical Xenotransplantation
Regulatory Documents and Guidelines
An overview of key steps in developing regulatory guidelines was listed in a position paper published in Xenotransplantation in 2000 and a summary of regulatory documents for Xenotransplantation was presented in Osaka in 2013.
Corneal Xenotransplantation
IXA has worked closely with WHO and various national regulatory bodies to establish detailed recommendations regarding safe, scientifically and ethically reasonable conditions that should be met in order to undertake a corneal xenotransplantation clinical trial.

An initial consensus statement on conditions for undertaking clinical trials of corneal xenotransplantation was published in Xenotransplantation in 2014. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.
Heart and Lung Xenotransplantation
A Xenotransplantation Advisory Committee lead by the president of the International Society for Heart and Lung Transplantation (ISHLT), Robert Kormos, considered the status of xenotransplantation and its potential role in the future treatment of patients with end-stage cardiac and pulmonary diseases in a global context. In particular, members considered the need for a new source of thoracic organs for transplantation, the potential of xenotransplantation to fulfill this need in comparison with other therapeutic modalities, the immune barriers and potential complications of clinical xenotransplantation, and some ethical, regulatory, and financial aspects. A position paper Report of the Xenotransplantation Advisory Committee of the International Society for Heart and Lung Transplantation: The Present Status of Xenotransplantation and Its Potential Role in the Treatment of End-Stage Cardiac and Pulmonary Diseases was published in Xenotransplantation in 2000. The authors emphasized that the field of xenotransplantation research, particularly that involving thoracic-organ transplantation, should be reviewed at intervals and revisions made to their conclusions and recommendations.
Islet Xenotransplantation
Consensus Statement on Conditions for Undertaking Islet Xenotransplantation Clinical Trials

IXA has worked closely with WHO and various national regulatory bodies to establish detailed recommendations regarding safe, scientifically and ethically reasonable conditions that should be met in order to undertake an islet xenotransplantation clinical trial.

The 2nd International Conference on Clinical Islet Xenotransplantation (ICCIX) took place in San Francisco on August 1, 2014. The objective of the 2nd ICCIX was to update the IXA Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet Products in Type 1 Diabetes, which was published in Xenotransplantation in 2009. Topics discussed included the regulatory framework, source pigs, pig islet cell products, preclinical efficacy and safety studies, recipient monitoring, patient selection, and ethical consideration. The updated IXA Consensus Statement will incorporate the current thinking of the participating opinion leaders active in the respective fields and will be published in a future issue of Xenotransplantation.
Young Investigator
Young Investigator
Activities
New activity list to come!

Lectures/Seminars
Members of the committee plan to launch monthly lectures or webinars which will cover different xenotransplantation topics. These lectures are intended for new or junior members who wish to broaden their knowledge on the current research in xenotransplantation.

Experimental Protocols
This section will catalog different protocols utilized by scientists in the field, such as cell isolation, antibody binding and more. They should provide valuable tools for students or new members in the field of xenotransplantation.

Visit the Young Investigator committee page

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