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Hastings Center News

Ethical and Policy Guidance for Translational Xenotransplantation Clinical Trials

Xenotransplantation is a novel experimental treatment that involves transplanting organs from nonhuman animals into humans to reduce the organ shortage—a public health problem. A new four-year research study, supported by the National Center for Advancing Translational Sciences of the National Institutes of Health, will identify appropriate ethical and policy guidance for translational xenotransplantation kidney clinical trials—studies that connect basic research with clinical practice.

Principal investigators are Karen Maschke, PhD, a research scholar at The Hastings Center; Michael Gusmano, PhD, a research scholar at The Hastings Center and a professor at the College of Health at Lehigh University; and Elisa J. Gordon, PhD, a professor at Northwestern University. Joseph Leventhal, MD, a transplant surgeon at Northwestern, is a co-investigator.

With input from an advisory committee comprised of translational scientists, transplant clinicians, transplant policy experts, and human subjects research experts, the research team will develop up-to-date ethics and policy recommendations and decision aids for transplant candidates, transplant clinicians, and institutional review boards that will review xenotransplantation clinical trial protocols.

“The recommendations and decision aids we develop will be specific to clinical trials in the U.S. involving kidneys from pigs,” said Maschke. “These materials will be adaptable for use in other national regulatory and policy contexts and for clinical trials involving other pig organs.”  

The Hastings Center has never shied away from the toughest ethical challenges faced by society.

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