There is a grave discordance between supply and demand for patients with failing organs largely due to an insufficient donor pool for transplantation. Xenotransplantation has been proposed as a solution to bridge this gap.
Recent success over the last decade in nonhuman primate models, due to emerging gene-editing technologies combined with novel immunosuppression regimens, has produced promising results in pancreatic islet cell, heart, lung, kidney and liver xenotransplantations.
As the prospect of xenotransplantation is realized, safety and ethical considerations have come to the forefront of discussion. The WHO and World Health Assembly have encouraged member states to form regulatory bodies to govern human xenotransplantation studies with the highest standards. Here, we summarize the current regulatory landscape governing preclinical advances toward the first human clinical trials.
aDepartment of Surgery, Cardiac Xenotransplantation Program, University of Maryland School of Medicine
bDepartment of Surgery, Johns Hopkins Hospital, Baltimore, Maryland
cDepartment of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, California, USA
Correspondence to Muhammad M. Mohiuddin, MD, Cardiac Xenotransplantation Program, University of Maryland School of Medicine, 10 S. Pine Street, MSTF 434B, Baltimore, MD 21201, USA. Tel: +1 410 706 6081; e-mail: firstname.lastname@example.org