[Table of Contents]

Volume: 27S1 • July 2001

Report of the Xenotransplantation Surveillance Workshop
Infection Control Database and Sample Archiving

III: CONCLUSIONS AND SUMMARY

An enhanced xenotransplantation surveillance system is one of many precautionary measures to reduce infectious disease risks to recipients, their offspring and third parties. A critical review of the literature along with an analysis of the survey results and discussion suggests that the current regulatory framework in Canada may benefit from the development of an interim policy on xenotransplantation clinical trials to deal with enhanced surveillance issues. Additionally, international harmonization on the surveillance of xenotransplantation clinical trials to reduce the infectious disease risks to recipients and third parties also seems warranted.

Although an appraisal of the literature on PERVs seems to indicate that there is at least a theoretical risk of PERV transmission to humans through xenotransplantation, recent evidence suggests this risk might be minimized in the near future. For example, there is preliminary evidence from Dr. Clive Patience, a principal scientist at BioTransplant Inc., that pig herds could be bred that do not produce infective, replication-competent PERVs⁽³³⁾. However, whether special breeding or cloning of animals may, in fact, eliminate the production of replication-competent endogenous or endemic viruses remains to be seen.

There remain several important issues about pre-clinical safety assessment, including the requirement for studies in NHPs (efficacy and safety) versus infectious disease risks (transmissibility of pig infectious agents to primates) and minimal follow-up times in animals, before clinical trials are considered in Canada.

In summary, national and international cooperation is needed to effectively devise and adopt enhanced surveillance measures for xenotransplantation that will identify, contain, and minimize infectious disease risks to recipients, their offspring and third parties worldwide. A number of problems and points to consider have been outlined in this report for future national and international discussion.

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