Our mission is to promote xenotransplantation as a safe, ethical, and effective therapeutic modality

Council Message - April 2024

Exciting Progress in Xenotransplantation Continues with Successful Transplantation of Genetically-Edited Pig Kidneys into Living Recipients
The IXA Community is excited by the recent successful implantation of gene-edited pig kidneys into living human recipients. Following the first two cases of clinical heart xenotransplantation at University of Maryland Baltimore, the world’s first successful transplant of a genetically-edited pig (porcine) kidney was performed at Massachusetts General (MGH) Hospital in Boston, USA on Saturday, March 16.

The recipient was a 62-year-old man living with end-stage kidney disease (ESKD) with a failed prior allograft and without functioning vascular access who was subsequently discharged from the hospital for continued care. Details are being prepared for peer-reviewed publication. This was a major milestone in advancing clinical xenotransplantation. This transplant was based on decades of preclinical xenotransplantation research at MGH and other xenotransplant research programs worldwide. The gene-edited pig kidney carried 69 genomic edits including multiple modifications to address immune and coagulation incompatibilities as well as inactivation of the porcine endogenous retrovirus (performed by eGenesis of Cambridge, Massachusetts).

A subsequent living xeno-kidney recipient at the NYU Langone Medical Center (NYU) in New York City, USA was for a 54 year old woman with heart and kidney failure who received a both a ventricular support device and subsequent gene edited combined thymo-kidney xenograft and is doing well. The added thymic graft is intended to enhance long term immune compatibility in the recipient. This compassionate use living xenotransplantation follows on the heels of studies at NYU of multiple xeno-kidney implants into brain dead human recipients.

Both are major steps in the quest to provide more readily available organs to patients. It is notable that the two teams have deployed differing immunosuppressive regimens and pigs carrying different genetic edits to achieve renal replacement. The field of transplantation will benefit from insights gained from this experience. These efforts depend on large teams at each center as well as important collaborations with industrial partners who have developed source animals, immunosuppressive agents, and diagnostic tools deployed for these therapies.

The field of xenotransplantation is most grateful to the two remarkable kidney recipients in these pioneering surgeries, whose courage and support have allowed these advances.

On behalf of the International Xenotransplantation Association Council

READ PRESS RELEASE FROM Massachusetts General Hospital (MGH)

BOSTON – MARCH 2024 - Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health care system, announced the world’s first successful transplant of a genetically-edited pig (porcine) kidney into a 62-year-old man living with end-stage kidney disease (ESKD). Surgeons from the Mass General Transplant Center conducted the four-hour- long surgery on Saturday, March 16. The procedure marks a major milestone in the quest to provide more readily available organs to patients.

The patient is recovering well at MGH and is expected to be discharged soon.

Under the leadership of Leonardo V. Riella, MD, PhD, Medical Director for Kidney Transplantation, Tatsuo Kawai, MD, PhD, Director of the Legorreta Center for Clinical Transplant Tolerance, along with Nahel Elias, MD, Interim Chief of Transplant Surgery and Surgical Director for Kidney Transplantation, a genetically-edited pig kidney with 69 genomic edits was successfully transplanted into a living patient. MGH transplant clinicians and surgeons have nearly 30 years of experience with xenotransplantation research. IXA members in attendance were recognized at the press briefing including Drs. David Sachs, David Cooper, Richard (Robin) Pierson, Joren Madsen, and Jay Fishman.

“Mass General Brigham researchers and clinicians are constantly pushing the boundaries of science to transform medicine and solve significant health issues facing our patients in their daily lives,” said Anne Klibanski, MD, President and CEO, Mass General Brigham. “Nearly seven decades after the first successful kidney transplant, our clinicians have once again demonstrated our commitment to provide innovative treatments and help ease the burden of disease for our patients and others around the world.”

“The tireless commitment of our clinicians, researchers and scientists to improving the lives of our transplant patients – both current and future – is at the very heart and soul of academic medicine and what it means to work and provide care at Mass General Brigham,” said David F. M. Brown, MD, President, Academic Medical Centers, Mass General Brigham. “We are so thankful to the incredible staff throughout our hospitals who helped make this surgery a success, and to the patient for his bravery and courage.”

“The success of this transplant is the culmination of efforts by thousands of scientists and physicians over several decades. We are privileged to have played a significant role in this milestone. Our hope is that this transplant approach will offer a lifeline to millions of patients worldwide who are suffering from kidney failure,” Kawai said.

The pig kidney was provided by eGenesis of Cambridge, Mass., from a pig donor that was genetically-edited using CRISPR-Cas9 technology to remove harmful pig genes and add certain human genes to improve its compatibility with humans. Additionally, eGenesis scientists inactivated porcine endogenous retroviruses in the pig donor to eliminate risks due to these organisms in humans. Dr. Jay Fishman, President-elect of IXA, Professor of Medicine, and Director of the MGH Transplant Infectious Disease Program, with eGenesis scientists have developed an extensive testing strategy for the pigs and for the kidney recipient to reduce potential risks of infection. The procedure was performed under a single FDA Expanded Access Protocol (EAP) which was rigorously reviewed by the FDA before its approval in late February. This compassionate use protocol also included infusion of novel immunosuppressant drugs, tegoprubart, provided by Eledon Pharmaceuticals, Inc., and ravulizumab, provided by Alexion Pharmaceuticals, Inc.

“We are grateful for the courageous contribution of the patient and to the advancement of transplantation science,” said Mike Curtis, Chief Executive Officer, eGenesis. “We congratulate our collaborators at MGH on this historic milestone. We also recognize the work and dedication of the eGenesis team that made this achievement possible. This represents a new frontier in medicine and demonstrates the potential of genome engineering to change the lives of millions of patients globally suffering from kidney failure.”

This successful procedure in a living kidney recipient is a further historic milestone in xenotransplantation and extends observations in decedent recipients and recent cardiac xenotransplants to clinical applications. Kidneys are the most common organ needed for transplant with end-stage kidney disease rates estimated to increase 29-68 percent in the U.S. by 2030.

“The real hero today is the patient, as the success of this pioneering surgery, once deemed unimaginable, would not have been possible without his courage and willingness to embark on a journey into uncharted medical territory said Joren C. Madsen, MD, DPhil, Director of the MGH Transplant Center.

“The continued success of this groundbreaking kidney transplant represents a true milestone in the field of transplantation. It also represents a potential breakthrough in solving one of the more intractable problems in our field, that being unequal access for ethnic minority patients to the opportunity for kidney transplants due to the extreme donor organ shortage and other system-based barriers. This health disparity has been the target of many national policy initiatives for over 30 years, with only limited success. An abundant supply of organs resulting from this technological advance may go far to finally achieve health equity and offer the best solution to kidney failure – a well-functioning kidney – to all patients in need.” Williams said

Ethical Considerations in Pig-to-Human Xenotransplantation

As part of our ongoing mission to provide our members with interesting multimedia events focusing on xenotransplantation, we are proposing a recent discussion on Ethical Considerations in Pig-to-Human Xenotransplantation presented by the Harvard Medical School Center for Bioethics.

IPITA-IXA-CTRMS 2023 Congress Recordings are Available

Many thanks to the over 600 attendees from 30 countries who attended and supported the 2023 Joint Congress of the IPITA, IXA and CTRMS in San Diego, California on October 26-29, 2023.

President's Message - November 2023

Muhammad Mansoor Mohiuddin

University of Maryland
Baltimore, MD, USA

Dear Friends and Colleagues,

Thank you, IXA members, for electing me as your president. I took office at a time when there is bloodshed going around the entire world, and thousands of innocent lives have been lost. During this tragic time, our XenoHeart team, were trying to save a single life of a patient who had heart failure and was denied any means to prolong his life. We transplanted a 10-gene modified pig heart in this patient, prolonging his life for 40 days. This patient and our first patient who lived for 60 days were thankful to the regulatory agency (FDA) and our team for giving them a few extra days to live. They knew they had very little chance of living for an extended period, but they took a chance with us so we refine what we have learned over the years in our animal models. Our team and I are indebted to the courage of these two patients and their families. They teach the value of each individual human life at a time when so many are being cut tragically short and inhumanity flourishes. We took the Hippocratic Oath to keep trying to save human lives.

All of us, the IXA members, have the same goal, and we have come a long way to start feeling that xenotransplantation has a real chance. I know most of you; we have worked together for years to reach this stage. Thousands are looking to us to provide them hope when they are being rejected for organ transplantation and are referred to hospice.

My goal during my presidency is to keep moving our field forward by fostering your collaboration. IXA has been the leader in pushing xenotransplantation towards the clinical realm. Now that we have entered the clinical space, we should strive to make the xenotransplantation option as good as, if not better, than allotransplantation. We must incorporate newer technologies to understand the remaining immunological and non-immunological hurdles. We must encourage the incorporation of young investigators and utilize their fresh and novel thinking to advance the field. While we do that, we need to reach out to the experienced members who are less active in the field but have much wisdom to offer. We must educate our communities regarding the xenotransplant option and its benefits. We must continue to engage our regulatory and ethics agencies and find common grounds to progress xenotransplantation as a standard care method.

Thanks again for allowing me to lead this Association and looking forward to taking giant strides with you all.

Muhammad Mansoor Mohiuddin
President, International Xenotransplantation Association

Congratulations to our recent award winners



International Xenotransplantation Association
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