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Volume: 27S1 • July 2001
Report of the Xenotransplantation Surveillance Workshop
Infection Control Database and
Sample Archiving
Ottawa, Ontario
March 31, 2000
Adobe Downloadable Document
(327 KB)
Table of Contents
OVERVIEW
- Why an Enhanced Surveillance System for Xenotransplantation in Canada?
I: INTRODUCTION
- Background to the Current Regulatory Framework for Xenotransplantation
in Canada
- Adverse Event Reporting in Canada
- Potential Attributes of an Enhanced Surveillance Scheme
- Enhanced Xenotransplantation Surveillance in Other Nations
- The Issue of Endemic Viruses
- The Issue of Endogenous Viruses
- Published Adverse Events in Xenograft Recipients
- Infectious Disease Risks of Endemic and Endogenous Porcine Viruses
II: SURVEY RESULTS AND DISCUSSION
- Patient Registry and Adverse Event Reporting Database
- Definition of Adverse Event for Xenotransplantation
- Linking Adverse Events to Xenozoonosis
- Criteria for Follow-Up Investigation of Potential Zoonosis
- Time Lines for Reporting Data and Adverse Events to Registry
- Sample Archiving
- Schedule for Recipient Archiving/Testing
- Pre-Clinical Work-Up on the Source Herd
- Surrogate Markers
- Testing for Unknown Pig Infectious Agents
- Xenozoonoses Outbreak Responses
III: CONCLUSIONS AND SUMMARY
IV: REFERENCES
V: APPENDICES
This report was compiled by Dr. Marian Laderoute from the results of a written
survey completed by participants at a Health Canada sponsored Xenotransplantation
Surveillance Workshop, March 2000, and from her analysis of the current literature
on xenotransplantation. The issue of xenotransplantation is characterized
by many different views. Health Canada supported this workshop in order to
assist in promoting discussion; however the opinions expressed by Dr. Laderoute
and the participants do not reflect a Health Canada policy on the issue.
Dr. Laderoute is the Research Manager, Blood Zoonotics Unit, Bloodborne
Pathogens Division. All correspondence should be addressed to Dr. Laderoute
at the following address:
Dr. Marian Laderoute
Research Manager, Blood Zoonotics Unit
Bloodborne Pathogens Division
Bureau of Infectious Diseases
Centre for Infectious Disease Prevention and Control
Health Canada, LCDC Building #6, Room 1420
Tunney's Pasture AL 060 1E2
Ottawa, Ontario K1A 0L2
tel: (613) 941-6087
fax: (613) 952-6668
e-mail: marian_laderoute@hc-sc.gc.ca
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