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The Use of the Pig-to-Human Decedent Model to Optimize Future Results in Clinical Xenotransplantation Trials

Award Number: P01AI181994
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/15/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2031

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The Use of the Pig-to-Human Decedent Model to Optimize Future Results in Clinical Xenotransplantation Trials - PROJECT SUMMARY – OVERALL Xenotransplantation has the potential to provide nearly unlimited organs for transplantation. Extension of xenograft survival in nonhuman primates (NHP) and xenotransplants to living and brain-dead humans have advanced the field toward clinical trials. Four gaps in knowledge remain to be filled before any human clinical trials of xenotransplantation can begin. We must first define the: 1) optimal immunosuppression regimen, 2) optimal genetics of the source animal, 3) humoral and cellular response to xenografts in humans, and 4) ability of the pig kidney to appropriately regulate human physiology. Only pig-to-human xenotransplants can provide this information. At NYU Langone, we developed an innovative decedent model to study the results of xenografts transplanted to humans and gain experience in the clinical management of xenograft recipients. We have now performed five decedent xenotransplants and monitored them up to 61 days after the transplant. Our preliminary data show that decedents have normal immune responses to xenografts, and that we can diagnose and treat antibody-mediated rejection of Gal-knockout thymokidneys. We now propose to perform 20 thymokidney xenotransplants and monitor the clinical, immunological, and physiological results in the decedents for up to 60 days, studying the human adaptive immune response to xenografts for the first time. Our program’s overarching hypothesis is that the decedent model will reveal critical information on the immune response to xenografts and the physiologic function of pig kidneys in recipient humans. Our program consists of four projects: Project 1 will study the effect of different immunosuppression regimens and different genetic modifications to the pigs on xenograft function and survival; Project 2 will use an innovative multi-omic approach to profile the human immune response to xenografts and assess physiologic changes in the decedent; Project 3 will examine the donor-specific T-cell response to xenografts (effector and regulatory T cells) and study the role of follicular T cells on potentiating the humoral immune response; and Project 4 will study the physiologic function of the pig kidney in the human milieu and in the context of possible immunologic injury. Findings in each project will inform, extend or complement studies pursued by other projects. The projects will be supported by a Molecular Science Core that will standardize and support multi-omic data collection and analysis. We also have an Administrative Core providing budgetary, logistical, and scientific oversight and statistical guidance. Collectively, these projects will provide a new level of understanding of the management of xenograft recipients and the human immune response to xenografts. Upon successful completion of the proposed research, we expect to be able to appropriately define the donor pig and treatment approach for the first clinical trials of kidney xenotransplantation, with the long-term goal of developing xenotransplantation into a standard clinical treatment option for organ failure.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $2,064,597 )
2026	2026	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	000	1	4/17/2026	NEW	$2,064,597
														Subtotal = $2,064,597

Grand Total All Awards = $2,064,597

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The Use of the Pig-to-Human Decedent Model to Optimize Future Results in Clinical Xenotransplantation Trials

Award Number: P01AI181994

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/15/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2031

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