Future path4 min read
Xenotransplantation
Xenotransplantation means transplanting, implanting or infusing live cells, tissues or organs from an animal source into a human. Research focuses on organs from gene-edited pigs; use in people is still experimental, and the main hurdles are rejection and the risk of infection passing from the animal.
As of June 2022 the first clinical studies in humans of transplanting whole organs from animals had not begun according to an FDA document, and this use requires an investigational new drug (IND) application. In the clinical trial registry today there is a phase I/II study of transplanting a genetically modified pig-derived kidney for patients with end-stage kidney failure, recruiting participants according to the registry as read on 8 October 2026.
In 2014 NIH researchers reported that pig hearts transplanted into baboons survived 600 days, and considered that this might pave the way for clinical trials for heart patients. The FDA warns of the possibility of transmission of cross-species retroviral infections that may stay dormant and cause disease years later, which is why the registered study includes lifelong follow-up covering testing for zoonotic infection.
- In widespread clinical use
- Approved for specific uses
- In clinical trials
- Preclinical
- Concept
As of 2022 studies of whole-organ transplantation in humans had not begun according to the FDA; and today there is in the trial registry a phase I/II study of transplanting a genetically modified pig kidney that is recruiting participants.
- Genetically modified pig kidney for patients with end-stage kidney failureIn clinical trials
A registered phase I/II study (NCT06878560) that began in October 2025, with an estimated 50 participants, and measures survival 24 weeks after transplantation.2
- Pig hearts for heart patients
NIH researchers reported in 2014 that pig hearts survived in baboons for 600 days; and the official sources we read did not cover later developments in humans.3
Status last checked: · What the maturity levels mean
What is this path?
Xenotransplantation is any procedure that involves the transplantation, implantation or infusion into a human recipient of live cells, tissues or organs from an animal source.
The currently registered study uses a kidney derived from a pig carrying intentional genomic modifications for transplantation purposes.
Where does the research stand?
As of June 2022 the first clinical studies in humans of whole-organ transplantation had not begun, and clinical use requires an investigational new drug (IND) application.
In 2014 NIH researchers reported that pig hearts transplanted into baboons survived 600 days, and considered that this might pave the way for clinical trials for heart patients.
The clinical trial registry shows a phase I/II study of transplanting a genetically modified pig kidney for patients with end-stage kidney failure who are ineligible for conventional transplantation or unlikely to receive a kidney within five years (see Chronic kidney disease); it began in October 2025 and is recruiting participants according to the registry as read on 8 October 2026.
What separates it from clinical use?
Rejection of the transplanted organ by the body is one of the greatest obstacles to the success of transplanting pig organs into humans.
It carries unique risks of transmission of zoonotic diseases to the recipient, including the possibility of cross-species retroviruses that may stay dormant and cause disease years later.
The FDA considers that pivotal animal studies should be designed in advance to assess the organ's long-term survival and safety.
Common questions
Has pig kidney transplantation become an available treatment option?
No, according to this page's sources; it is in a phase I/II clinical study, and we did not find on the FDA page anything indicating approval of any product of this kind. The treatment options for kidney failure are decided by the specialist doctor.24
Questions for your doctor
- What treatment options are available for my condition now, and am I a candidate for a kidney transplant from a human donor?
- Is there a clinical trial suitable for me, and what are its risks and follow-up requirements?
References
- 1U.S. FDA. FDA Briefing Document — Cellular, Tissue, and Gene Therapies Advisory Committee (June 29–30, 2022): xenotransplantation. www.fda.gov/media/159213/downloadHealth agencies & guidelines · Accessed 2026-10-08
- 2ClinicalTrials.gov (U.S. NIH). Study record NCT06878560 — gene-edited pig kidney (xenokidney) in patients with end-stage renal disease. clinicaltrials.gov/study/NCT06878560Health agencies & guidelines · Accessed 2026-10-08
- 3NIH Intramural Research Program (NIH Catalyst). Extending Organ Survival. irp.nih.gov/catalyst/22/4/extending-organ-survivalHealth agencies & guidelines · Accessed 2026-10-08
- 4U.S. FDA. Xenotransplantation. www.fda.gov/vaccines-blood-biologics/xenotransplantationHealth agencies & guidelines · Accessed 2026-10-08
Review status: Edited content · Last updated:
Change log
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Educational content only — no diagnosis, and no substitute for a clinician.