Transfusion Transmitted Injuries Section
Potential Future Activities

Xenotransplantation Surveillance

Xenotransplantation (XTP) is defined as any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live, nonhuman animal cells, tissues or organs.

Xenotransplantation, while having the potential to save human lives, also has the potential for introducing both known and unknown infectious agents of animal origin into the human population. The animal agents that are introduced into recipients may have the ability to adapt to the new environment and survive among the recipients. This situation introduces a significant risk for establishment of infection in the recipient host with potential risk of progression to disease and transmission to the general human population.

In Canada, xenotransplantation is not a routine medical practice, and no clinical trial has so far been conducted. Health Canada funded the Canadian Public Health Association to form a Public Advisory Group and carry out public consultation to better understand the public's opinion on this issue. A final report of this consultation is now available at the website: http://www.xeno.cpha.ca/english/finalrep/page1.htm.

When clinical trials for XTP are permitted, a comprehensive surveillance system, as indicated by both Health Canada's Proposed Canadian Standard for Xenotransplantation and the US Draft PHS Guideline on Infectious Disease Issues in Xenotransplantation will be a critical component of such activities to protect the health of Canadians. The surveillance system will consist of pretransplant screening of the source animal to minimize the risk of transmission of known animal agents to the recipients of xenografts, and posttransplant surveillance. The posttransplant surveillance will include a lifelong national registry and a central archiving facility for biological specimens. The system will allow for tracking of xenograft recipients and will maximize the possibility of detection and containment of xenogeneic infections among recipients, should they happen.

[Blood Safety Surveillance and Health Care Acquired Infections Division]