Dear Friends and Colleagues,
I am excited to be able to provide the ongoing updates about our field, with several major achievements taking place in xenotransplantation. These are specifically the publication of the most recent clinical trials undertaken, as reported in our last Newsletter.
We have realized the advent of clinical xenotransplantation, with kidneys and hearts from genetically modified pigs being transplanted into human patients. This has been possible only based on decades of research, preclinical testing in non-human-primate (NHP) models, and provision of these data to support the move to the clinic. At this time, it is important to remember that many pre-clinical trials of ground-breaking importance provide the underpinning of clinical application. These trials are the start of clinical transplants in select cases, including the decedent model of preclinical research as an addendum to NHP models, and potentially, as an additional step to validate NHP data for some organs.
In moving toward the clinic, there have been numerous ideas postulated recently by outside organizations to ensure that all facets are covered appropriately and that xenotransplantation becomes the major advance we have all believed and hope it to be. However, it is important to note that our IXA Council has been working for decades to develop guidance for our xenotransplant community in advance of other organization’s recent interests. The IXA Council along with the IXA membership, experts in various specialties, the TTS and the World Health Organization (WHO) have been working for decades to ensure appropriate guidance and precautions be developed prior to any major clinical trials being undertaken.
In this regard the IXA established a registry following the recommendations by a panel of experts gathered by the WHO in 2005, and the Xenotransplant Inventory was then established with the aim to collect practices of human xenotransplantation worldwide (www.humanxenotransplant.org). The website was activated in October 2006 by the IXA, along with support from the University Hospital Geneva and the WHO; it has been recording data, and providing statistics and reports for over 16 years. In addition, the IXA Council has actively driven the development and publication of relevant guidance documents, position papers, expert panel recommendations, document reviews and development, protocol development and reviews in conjunction with various governments and authorities.
Over many years, IXA has undertaken substantial consultation with national jurisdictions, including the US Food and Drug Administration (FDA), Centre for Biologics Evaluation and Research, Office of Cellular Tissues and Gene Therapies - Tissues (US FDA Cber), Cellular & Gene Therapy (US FDA Cber), and Xenotransplantation (US FDA Cber), the Chinese FDA, the European Medicines Agency (EMA), the Australian Therapeutic Goods Administration (TGA), the (now disbanded) UK Xenotransplantation Interim Regulatory Authority (UKXIRA), Spanish Organizacion Nacional de Transplantes (ONT), The Administración Nacional de Medicamentos, Alimentos Tecnología Médica of Argentine Republic (ANMAT), and the South Korean Ministry of Food and Drug Safety (MFDS). The IXA is continuing to develop updated policy documents and will continue to move forward running joint workshops and meetings to guide policy and guidance for best practice as we move toward clinical trials. We look forward to further rapid advances in our field based on our guidance.
As part of the IXA’s ongoing mission to inform and educate its membership and the broader transplant community, we have conducted polling of our membership. They indicate that they want to learn more about Xenotransplantation and its most recent advances. As one means to address this in line with newer technology platforms, Professor Rita Bottino is developing a Podcast series that will provide some basic insights into the newest advances in our field, with interviews and presentations from senior IXA members.
We look forward to receiving both feedback and suggestions from members across all levels. If you have an interesting topic for discussion as a Podcast, or if you have any feedback you would like to raise, please do so via email to Suzanne Landis firstname.lastname@example.org at the TTS office, who will direct this on to Rita and the team for review.
The planning has commenced for next year’s tripartite meeting of IPITA, IXA and CTRMS in San Diego, USA between 26th – 30th October 2023. This is the 3rd such joint congress; the Congress Board consisting of the Executives of the three associations are well underway with organising this event. Professor Raja Kandaswamy (IPITA) is the Congress Chair, Professor Wayne Hawthorne (IXA) is the Scientific Program Chair and Professor Klearchos Papas (CTRMS) is the Finance Chair.
The preliminary meeting program has been developed. The Scientific Program Committee are developing the individual sessions, including the Plenary, State of the Art, and individual specialized sessions for the meeting. We are pushing for several combined sessions so that we can share experiences, technologies and information across the joint societies and their attendees, while devoting dedicated sessions to Xenotransplantation. Visit www.sandiego2023.org.
In the new year, please rally your teams and be ready to submit abstracts for this meeting when the call for abstracts comes out. This will be an exciting cutting-edge congress and we hope that many of our IXA members will be able to attend this in-person meeting next year.
Professor Wayne J. Hawthorne