# Informing Ethical Translation of Xenotransplantation Clinical Trials

> **NIH NIH R01** · HASTINGS CENTER, INC. · 2022 · $467,833

## Abstract

PROJECT SUMMARY
Xenotransplantation (XTx) is a novel experimental treatment that involves transplanting organs from nonhuman
animals into humans. Due to the scarcity of human organs for transplantation, XTx could help alleviate the
organ shortage, which is an ongoing public health problem. Early experimental xenotransplants were
performed in the U.S. from the 1960s to 1990s, involving a chimpanzee kidney, a baboon heart, and a baboon
liver. Despite holding great promise, XTx experiments ended in the late 1990s due to scientific and ethical
challenges. Today, XTx is undergoing a renaissance. Scientific advances in immunosuppression and genome
editing techniques have mitigated the risk of zoonotic disease transmission. The transplant field is primed to
conduct XTx clinical trials and then translate findings to clinical care. However, available guidelines for
conducting XTx clinical trials are outdated, do not address advances in the science of XTx, do not account for
stakeholders’ concerns, and do not consider the impact on policy changes to organ allocation. The overall
objective of the proposed study is to identify appropriate ethical and policy guidance for translational
solid organ XTx clinical trials. The research team includes national bioethics leaders at The Hastings
Center, Northwestern University, and Rutgers University, with The Hastings Center serving as the data
coordinating center. We will conduct in-depth interviews with transplant patients, transplant clinicians,
transplant regulators, and human subjects ethics regulators, and obtain input from an Ethics and Policy
Advisory Committee comprised of experts in translational science and bioethics to: (1) assess XTx
stakeholders’ perceptions and concerns about ethical and policy challenges for XTx clinical trials; (2) develop
XTx stakeholder decision aids that help patients, clinicians, and institutional review boards to evaluate, design,
and oversee XTx clinical trials, respectively; and (3) develop recommendations for the ethical translation of
XTx clinical trials. Updated guidance and decision aids will facilitate ethical decision-making about XTx clinical
trials. The innovative and timely decision aids will contain generalizable ethical principles for human subjects
research protections and policy considerations regarding organ allocation that will apply to XTx clinical trials
involving other organs. Future next steps include designing a study to test the influence of the decision aids on
the choices of patients, IRBs, and transplant centers about XTx kidney clinical trials.

## Key facts

- **NIH application ID:** 10465264
- **Project number:** 5R01TR003844-02
- **Recipient organization:** HASTINGS CENTER, INC.
- **Principal Investigator:** Elisa J Gordon
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $467,833
- **Award type:** 5
- **Project period:** 2021-08-09 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10465264

## Citation

> US National Institutes of Health, RePORTER application 10465264, Informing Ethical Translation of Xenotransplantation Clinical Trials (5R01TR003844-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10465264. Licensed CC0.

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