In January 2022, surgeons at the University of Maryland Medical Center implanted the heart of a genetically modified pig into a 57-year-old man in a procedure known as xenotransplantation (XTx). XTx is an experimental treatment in which a human receives a whole organ from a nonhuman animal. XTx currently is performed on an emergency basis with FDA approval. With the first in-human clinical trials anticipated in the near future, XTx, if successful, could provide desperately needed donor organs for some of the more than 100,000 patients on the national transplant waiting list. However, many critical questions remain.
Michael Gusmano, a professor of health policy in Lehigh’s College of Health, has partnered with colleagues from bioethics research institute The Hastings Center, Northwestern University and Rutgers University to ask those questions, with the goal of providing up-to-date ethical and policy guidance to patients, clinical teams, and the Institutional Review Boards (IRB) and regulators involved with XTx clinical trials.
To assess perceptions and concerns about ethical and policy issues, Gusmano and his colleagues are conducting in-depth interviews with transplant patients and clinicians, as well as transplant and human subjects ethics regulators. The researchers will use the information they gather to develop innovative XTx decision aids for stakeholders and provide recommendations for the ethical translation of XTx clinical trials. The four-year project, “Informing Ethical Translation of Xenotransplantation Clinical Trials,” is funded by the National Institutes of Health (NIH).