A multisite research team has issued ethical and policy recommendations for first-in-human clinical trials involving the transplantation of pig kidneys into humans. The first trial has been approved by the U.S. Food and Drug Administration and could begin this year.
Transplantation of animal organs into humans, or xenotransplantation, holds promise as a strategy to alleviate the scarcity of human organs. Clinical trials are essential for determining whether animal organs are safe in humans and how well the organs function in humans.
The recommendations are the culmination of a four-year study funded by the National Center for Advancing Translational Sciences of the National Institutes of Health and led by Karen J. Maschke , a senior research scholar at The Hastings Center for Bioethics; Michael K. Gusmano , a professor of health policy at Lehigh University; and Elisa J. Gordon , a professor of surgery at Vanderbilt University Medical Center.
The study engaged key stakeholders—including kidney patients on the transplant waiting list for a human kidney, transplant clinicians, and experts in human subjects research ethics—to assess their perceptions of ethical and policy challenges to conducting pig kidney clinical trials. The study also sought guidance from an ethics and policy advisory committee, which included transplant recipients and a living kidney donor.
The recommendations focus on eligibility for participation in a pig kidney clinical trial, monitoring transplant recipients for infectious diseases from the pig kidney, and metrics for evaluating the success of pig kidney clinical trials.
The research team also developed practical tools for patients, transplant teams, institutional review boards, and researchers conducting pig kidney clinical trials:
• A decision-aid for kidney patients considering whether to enroll in a pig kidney clinical trial
• An informed consent prototype for xenotransplant research teams to give to prospective participants
• Case studies and a teaching guide for transplant teams to help them reflect on ethical issues about pig kidney clinical trials and become better prepared to conduct such trials
• A checklist for institutional review boards reviewing research study protocols and informed consent forms for pig kidney clinical trials
More information about the study and its recommendations can be found here .
