REGULATORY ASPECTS OF CLINICAL XENOTRANSPLANTATION

Abstract

Living organ, tissue, or cell transplantation from one species to another is known to as xenotransplantation. The history of xenotransplantation is just as ancient as that of allogeneic transplantation. Early attempts were attempted when it was uncertain exactly, on an immunologic level, causes organ rejection. With the emergence of potent immunosuppressive medicines and concurrent advancements in the field of genetic engineering, a new perspective on the role of xenotransplantation as a tactic to resolve the disparity between the number of applicants on the waitlist and the available organs has developed. Although a xenotransplant clinical trial involving human subjects appears to be theoretically viable, it requires a stringent regulatory framework on both a national and international level to ensure both the individuals' and the public's safety. Several scientists in the United States urged the FDA to prohibit cross-species transplantation research until ethical concerns and health risks are addressed at the public conference on xenotransplantation that was held in January 1998. Clinical studies that are being conducted cautiously and with precision were approved by the FDA as suitable. ARMBA and the roles of the relevant governmental organisations and healthcare institutions are the focus of the present rules regulating the conduct of xenotransplant clinical trials in Korea. In accordance with the standards of the international guidelines, Korea is prepared to perform a clinical experiment involving xenotransplantation on humans. In accordance with the ARMBA and other relevant laws and regulations, the appropriate governmental authorities would work together to control the xenotransplant clinical study.