Correspondence

Guidelines for Xenotransplantation

N Engl J Med 2003; 349:1294-1295September 25, 2003

Article

To the Editor:

Xenotransplantation provides a potentially promising solution to the shortage of human organs and tissues and offers advantages over other approaches. The development of genetically modified pigs that lack expression of the α-1,3-galactosyltransferase target of humoral rejection is particularly promising.1 Although the possibility of introducing new infections from source animals into humans has been a concern,2 such transmission has apparently not occurred in xenotransplantations to date.3 Nevertheless, this theoretical risk mandates caution in clinical xenotransplantation. Consequently, considerable effort has been made in several countries to develop guidelines for the husbandry of source animals and for the monitoring of recipients. We believe that clinical xenotransplantation should be performed only with oversight by a governmental regulatory agency that has such guidelines (e.g., those of the U.S. Food and Drug Administration4). Source animals should be obtained from closed colonies from which known and potential pathogens have been excluded, and research subjects should be monitored appropriately and specimens archived.

Several countries are performing or planning clinical xenotransplantation (e.g., pig islet-cell and Sertoli-cell transplantation in Mexico and goat hepatocyte transplantation in India5), and some of these procedures are performed by commercial enterprises for cosmetic or medical treatment (e.g., rejuvenating therapies and treatment with shark cells for spinal cord injuries). Given that people may freely travel to undergo such procedures, international cooperation is needed to develop universal procedures and standards for oversight, including ethical and monitoring guidelines. Without such cooperation, the efforts of individual nations to minimize risks may be thwarted. For example, people who live in countries that have regulatory guidelines may travel to countries without regulation for their xenotransplants and then return home without monitoring; recipients who live in countries that lack guidelines may enter countries that do have guidelines but remain unidentified and unmonitored there.

In addition to working toward international guidelines, we should encourage public health authorities in countries that do regulate xenotransplantation to develop ways to identify persons who enter such a country after undergoing xenotransplantation abroad and to ensure monitoring. Requirements for public health reporting should also be developed for physicians who see patients who have undergone xenotransplantation in foreign countries. Without such measures, people who have received xenotransplants abroad will not be monitored.

Megan Sykes, M.D.
Massachusetts General Hospital, Boston, MA 02129
megan.sykes@tbrc.mgh.harvard.edu

Mauro Sandrin, Ph.D.
Austin Research Institute, Melbourne, VIC 3084, Australia

Anthony D'Apice, M.D.
St. Vincent's Hospital, Melbourne, VIC 3065, Australia

for the Ethics Committee of the International Xenotransplantation Association

5 References

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   Guidance for Industry: source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans. Rockville, Md.: Food and Drug Administration, 2001.
   

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Citing Articles (11)

Citing Articles

1. 1

   Peta S. Cook, Gavin Kendall, Mike Michael, Nik Brown. (2011) The textures of globalization: biopolitics and the closure of xenotourism. New Genetics and Society 30:1, 101-114
   CrossRef

2. 2

   Philip J. O’Connell. (2009) Chapter 6: Patient selection for pilot clinical trials of islet xenotransplantation. Xenotransplantation 16:4, 249-254
   CrossRef

3. 3

   David JG White. (2007) Islet xenotransplantation. Current Opinion in Organ Transplantation 12:2, 148-153
   CrossRef

4. 4

   P. P. M. Rood, D. K. C. Cooper. (2006) Islet Xenotransplantation: Are We Really Ready for Clinical Trials?. American Journal of Transplantation 6:6, 1269-1274
   CrossRef

5. 5

   Philip J OʼConnell, Andrew M Lew, Peter J Cowan, Sarah L Londrigan, Wayne J Hawthorne, Mark Nottle, Anthony JF dʼApice. (2006) Islet xenotransplantation: progress towards a clinical therapy. Current Opinion in Organ Transplantation 11:2, 174-179
   CrossRef

6. 6

   Pascal Bucher, Philippe Morel, Leo H. Buhler. (2005) Xenotransplantation: an update on recent progress and future perspectives. Transplant International 18:8, 894-901
   CrossRef

7. 7

   Megan Sykes. (2005) Commentary: World Health Assembly Resolution 57.18 on Xenotransplantation. Transplantation 79:6, 636-637
   CrossRef

8. 8

   Richard N Pierson. (2004) Xenotransplantation at the crossroads. Xenotransplantation 11:5, 391-393
   CrossRef

9. 9

   Gilles Blancho, Joanna Ashton-Chess, Jean-Paul Soulillou. (2004) Xenotransplantation in the pig to primate model. Current Opinion in Organ Transplantation 9:2, 181-185
   CrossRef

10. 10

    Megan Sykes, Mauro Sandrin, Emanuele Cozzi, Michael A. Rees. (2004) World Health Organization resolution on xenotransplantation. Xenotransplantation 11:3, 224-225
    CrossRef

11. 11

    Leo Buhler. (2004) January-October, 2003. Xenotransplantation 11:1, 3-10
    CrossRef