Xenotransplantation regulation and development
Vietnam successfully performed its first pig kidney transplant in a human at the Military Hospital 103 in Hanoi on June 30, 2026, utilizing a genetically modified pig kidney. As of July 8, 2026, the UAE has initiated a public consultation to regulate xenotransplantation, while Japan's PorMedTec Co. plans clinical trials for pig-to-human kidney transplants by 2028, addressing a shortage of 14,800 kidney donors. The U.S. FDA has authorized broader clinical trials, following a patient surviving over eight months with a gene-edited pig organ and another's pig kidney functioning for 271 days. A Chinese team also performed a combined pig liver and kidney transplant in June 2026, with organs functioning for nearly five days, demonstrating significant global advancements in xenotransplantation to combat organ shortages.
Timeline
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July 2026 — 1 developments
UAE launches public consultation on xenotransplantation and 3D bioprinted tissue regulation
The UAE has initiated a public consultation process to establish regulations for xenotransplantation and 3D bioprinted tissues. This move aims to address safety, ethics, and future applications in response to the global organ shortage.
June 2026 — 4 developments
Vietnam performs first pig kidney transplant in human
Vietnam has successfully performed its first pig kidney transplant in a human at the Military Hospital 103 in Hanoi. The kidney was sourced from a genetically modified pig, marking a significant step in xenotransplantation efforts to address the global organ shortage.
Japan to Launch First Clinical Trials of Pig Kidney Transplants by 2028
Japan's PorMedTec Co. plans to launch the country's first clinical trials for pig-to-human kidney transplantation as early as 2028. These trials will utilize genetically modified pig cells imported from the US company eGenesis. The initiative aims to address Japan's significant shortage of donor organs, with approximately 14,800 people currently awaiting kidney transplants.
Study Details Reversal of Pig Organ Rejection in Humans, Offers Xenotransplant Insights
A study published in Nature in November 2025 detailed how physicians successfully reversed a human's rejection of a pig organ twice, offering crucial insights into immune mechanisms for xenotransplant success. This follows a patient at NYU Langone Health whose gene-edited pig kidney functioned for 130 days in late 2024 before rejection due to an infection.
Chinese Team Performs First Combined Pig Liver and Kidney Transplant in Human
A Chinese team performed the first-ever combined transplant of a pig liver and kidneys into a human patient in June 2026, with the organs functioning for nearly five days. Additionally, a leading US surgeon stated in December 2025 that gene-edited pig organs could potentially become superior to human ones, with the first transplant of a trial already performed.
April 2026 — 4 developments
Tim Andrews, recipient of gene-edited pig kidney, dies seven months after transplant
Tim Andrews, a recipient of a gene-edited pig kidney transplant in January 2025, has died after seven months. His transplanted kidney had been functioning, filtering waste and producing urine, before his death. This case is part of ongoing research into xenotransplantation to address organ shortages.
FDA authorizes expanded xenotransplantation clinical trials after promising results
The U.S. Food and Drug Administration has authorized more extensive clinical trials for xenotransplantation, potentially including over thirty patients from multiple transplant facilities. These trials follow promising results, such as a porcine kidney functioning in a human for a record 271 days before removal due to proteinuria, and another recipient living without dialysis since a June transplant.
NYU Langone Surgeons Transplant Genetically Modified Pig Kidney into Living Patient
Surgeons at NYU Langone transplanted a genetically modified pig kidney into a living patient in late 2025, a procedure described as a rare milestone. Early data from these trials show some kidneys functioning for months, offering cautious evidence of the approach's viability. The US Food and Drug Administration (FDA) has approved clinical trials, signaling a move towards more systematic research beyond compassionate-use cases.
Patient survives eight months with gene-edited pig organ; FDA clears trials for engineered organs
A patient has survived for over eight months following a gene-edited pig organ transplant, a milestone highlighting xenotransplantation's progress. Biotechnology companies are now cleared by the FDA to initiate clinical trials evaluating genetically engineered pig organs. Massachusetts General Hospital had performed four xenotransplants in living recipients as of January 8, 2026, with patients experiencing significant benefits.
March 2026 — 4 developments
Vatican states xenotransplantation can be morally justifiable under strict conditions
The Vatican has stated that xenotransplantation can be morally and ethically justifiable under strict conditions. A second patient received a gene-edited pig kidney transplant at Massachusetts General Hospital in January 2025, and eGenesis received FDA clearance for an expanded trial of its pig kidney transplants.
Dr. Robert Montgomery predicts unlimited pig organs for human transplants within our lifetime
Surgeon Dr. Robert Montgomery predicts that unlimited pig organs for human transplants could be achievable within our lifetime, aiming for no immunosuppression and an unlimited supply. He notes that gene-edited pigs are already in clinical trials, with some using thymus transplants to help reduce the need for immunosuppression by inducing tolerance.
Gene-edited pig liver supports Chinese patient for three days
A gene-edited pig liver successfully supported a Chinese patient with liver failure for three days, serving as a bridge to a human transplant, according to a report in Nature Medicine. Separately, a new paper in Advanced Biology argues that xenotransplantation cannot solve the organ shortage due to high costs and safety concerns, highlighting risks like rejection and infectious disease transmission.
Researchers develop spray-on technology to deliver immunosuppressants to transplanted organs
Researchers have developed "Immune-Shield," a novel spray-on technology using mussel-derived adhesive protein to deliver immunosuppressants directly to transplanted organs. This method aims to suppress immune rejection, a major hurdle in xenotransplantation, without the systemic side effects of oral or injected immunosuppressants. The spray-on coating delivers drugs directly to the transplant site, significantly reducing immune cell infiltration and inflammatory responses in xenotransplantation experiments.
February 2026 — 5 developments
Chinese researchers successfully treat liver failure patient with gene-edited pig liver for 66 hours
Chinese researchers have successfully treated a liver failure patient using a gene-edited pig liver in an ex vivo perfusion system for 66 hours. The pig liver temporarily assumed detoxification, synthetic, and metabolic functions, showing significant improvement in the patient's liver function indicators. This extracorporeal life-support approach offers a potential bridging therapy for patients awaiting liver transplants.
Gene-edited pig liver supports human patient for 171 days, setting new record
A gene-edited pig liver has successfully supported a human patient for 171 days, establishing a new record for pig organ function in a living individual. This breakthrough extends the potential for managing patients with failing livers, offering a temporary solution while awaiting transplants or recovery.
FDA approves clinical trial for genetically modified pig liver to filter patient blood
A new clinical trial, approved by the FDA, will test a genetically modified pig liver used externally to filter a patient's blood. This approach aims to provide temporary life support for failing human livers, giving them time to recover or await a transplant. The trial addresses the critical shortage of donor organs.
Patient receives gene-edited pig liver therapy in global medical first
A patient with liver failure is in stable condition after receiving a novel therapy using a gene-edited pig liver, a procedure hailed as a global medical first. This extracorporeal perfusion technique connects the patient's circulatory system to a pig's liver outside the body, performing essential functions like detoxification and metabolism.
Alabama Woman Thrives 61 Days After Pig Kidney Transplant, Setting New Record
An Alabama woman has reportedly thrived for over 61 days after receiving a pig kidney transplant, setting a new record for a living recipient of a xenotransplant. This marks a significant advancement in the field of organ transplantation.
December 2025 — 1 developments
Gene-edited pig kidney transplant trial begins in humans, aims to surpass human organs
A clinical trial involving the transplantation of gene-edited pig kidneys into living humans began with the first procedure completed in October 2025. Experts believe these organs could eventually surpass human ones in quality. The trial aims to address the critical shortage of human organs, with six patients initially involved.
November 2025 — 3 developments
Scientists reverse rejection of gene-edited pig kidney in human for 61 days
Scientists have successfully reversed the rejection of a gene-edited pig kidney in a brain-dead patient, marking the longest survival of a pig organ in a human to date. Rejection episodes occurring over 61 days were reversed using existing medications, offering hope for overcoming immune response hurdles in pig organ transplants.
Researchers identify immune reactions causing pig kidney transplant rejection in humans
Researchers have made a significant breakthrough by identifying the specific immune reactions that lead to the rejection of pig kidney transplants in humans. This discovery provides clear targets for developing therapies to improve the success rate of xenotransplantation.
NYU Langone Health Begins First Gene-Edited Pig Kidney Transplant Surgery in Clinical Trial
NYU Langone Health begins the first surgery in a clinical trial (EXPAND study) testing gene-edited pig kidney transplants in patients with end-stage renal disease.
October 2025 — 1 developments
Genetically Engineered Pig Liver Supports Human for 171 Days in World-First Xenotransplant
The world's first auxiliary liver xenotransplant from a genetically engineered pig to a living human recipient was reported in October 2025, with the patient surviving for 171 days. This pioneering case demonstrates that modified porcine livers can support human metabolic functions.
August 2025 — 1 developments
Researchers Transplant Genetically Modified Pig Lung into Human, Chinese Hospital Uses Gene-Edited Pig Liver
Researchers achieved a world-first by transplanting a genetically modified pig lung into a brain-dead human recipient, where it remained functional for nine days without rejection or infection. Separately, a Chinese hospital reported a patient with liver failure showing stable condition after receiving a gene-edited pig liver in an extracorporeal perfusion treatment, a global medical first.
February 2025 — 2 developments
Massachusetts General Hospital performs second gene-edited pig kidney transplant; NYU Langone Health begins clinical trial
Massachusetts General Hospital performed its second transplant of a gene-edited pig kidney, while NYU Langone Health initiated the first clinical trial for such transplants. Researchers at NYU Langone Health have identified and overcome immune reactions that previously caused rejection in pig-to-human kidney xenotransplants, mapping immune cell interactions and successfully reversing rejection.
FDA approves first multi-patient clinical trials for genetically modified pig kidney transplants
The FDA greenlights the first multi-patient clinical trials for genetically modified pig kidney transplants in humans, involving companies United Therapeutics and eGenesis.
January 2025 — 1 developments
Massachusetts General Hospital performs second gene-edited pig kidney transplant
Massachusetts General Hospital performs its second gene-edited pig kidney transplant into a living person, who is later discharged with the organ functioning well.
November 2024 — 1 developments
Towana Looney Discharged After Receiving 10-Gene-Edited Pig Kidney at NYU Langone
Towana Looney receives a 10-gene-edited pig kidney at NYU Langone and is discharged, becoming the longest-living person with a pig kidney at the time of publication.
May 2024 — 2 developments
Chinese surgeons perform first successful pig-to-human lung transplant
Surgeons in China perform the first successful transplant of a lung from a genetically modified pig into a brain-dead human, expanding xenotransplantation to another organ type.
Richard Slayman, first gene-edited pig kidney recipient, dies two months post-transplant
Richard Slayman, the first living recipient of a gene-edited pig kidney, passes away two months post-transplant, though his death was not believed to be related to the transplanted organ.
March 2024 — 4 developments
eGenesis Receives FDA Clearance for Gene-Edited Pig Kidney Clinical Trial
The first living patient, Richard Slayman, received a gene-edited pig kidney on March 16, 2024, at Massachusetts General Hospital, with the procedure offering hope for alleviating the critical shortage of human kidneys. Slayman died two months later, with no indication his death was related to the transplant. In September 2025, eGenesis received FDA clearance for its Investigational New Drug application to begin a clinical trial for a genetically engineered pig kidney, and a clinical trial involving gene-edited pig kidneys began at NYU Langone.
Massachusetts General Hospital performs world's first genetically-edited pig kidney transplant
Massachusetts General Hospital performed the world's first successful transplant of a genetically-edited pig kidney into a living patient on March 16, 2024. The FDA approved clinical trials for gene-edited pig kidney transplants in February 2025, offering a potential future option for thousands awaiting transplants. Experts believe these pig organs could eventually surpass human donors in quality.
UAB announces successful transplant of gene-edited pig kidneys into human
The University of Alabama at Birmingham (UAB) announced the first peer-reviewed research detailing a successful transplant of gene-edited pig kidneys into a brain-dead human. This procedure involved pig kidneys with 10 key gene edits.
Massachusetts General Hospital performs world's first gene-edited pig kidney transplant in human
Massachusetts General Hospital performs the world's first successful transplant of a gene-edited pig kidney into a living human, Richard Slayman, who had end-stage kidney disease.
January 2024 — 1 developments
eGenesis Pig Kidney Functions in Human for Record 271 Days
A porcine kidney from an eGenesis pig has functioned in a human recipient for a record 271 days as of December 10, 2025, offering hope for the global organ shortage. Clinical trials for transplanting genetically modified pig kidneys into humans were approved by the FDA on February 6, 2025, with experts suggesting these organs could eventually surpass human ones due to advancements in gene editing.
January 2022 — 1 developments
University of Maryland School of Medicine performs first gene-edited pig heart transplant
The University of Maryland School of Medicine performs the first gene-edited pig heart transplant into a living human, David Bennett Sr., a groundbreaking procedure for a patient with terminal heart disease.
September 2021 — 1 developments
Dr. Robert Montgomery performs world's first gene-edited pig-to-human kidney transplant
Dr. Robert Montgomery performs the world's first gene-edited pig-to-human kidney transplant in a neurologically deceased person at NYU Langone Health, marking the first direct human test of a gene-edited organ.
January 2019 — 1 developments
Macaque survives over a year with pig kidney xenotransplant
A macaque survives for over a year with a life-supporting kidney xenotransplanted from a genetically altered pig, demonstrating significant preclinical success.
January 1990 — 1 developments
Pigs identified as preferred animal source for xenotransplantation due to organ similarity and genetic modification availability
Pigs are identified as the preferred animal source for xenotransplantation due to their organ size similarity to humans and their availability for genetic modification.