REGULATIONS

 

As xenotransplantation comes into more regular usage, guidelines will need to be adopted regulating the conditions under which donor animals are bred and their procurement. There is also some concern over the possible transport of transgenic animals and/or their organs (both in and out of patients) across international lines. But as yet, no firm agreements have been negotiated.

In the United States, the issue has been delegated to the FDA, which has so far adopted the following:

The FDA Draft Guideline for Xenotransplantation

 

1. The Clinical Plan

*The transplant team should include individuals such as the surgeon, infectious disease physician, veterinarian, transplant immunologist, infection control specialist, and clinical microbiologist.

*The clinical center should be associated with an accredited virology and microbiology laboratory.

*The protocol should be reviewed by the clinical center Biosafety Committee, Institutional Animal Care and Use Committee, and the Institutional Review Board. Protocols are subject to review and approval by FDA.

*The protocol should describe the screening methods for known infectious agents before transplantation.

*The informed consent process should include disclosure of the potential risks to the recipient, the family, or close contacts (especially sexual), and the need to archive pre- and post-transplant serum specimens for long-term follow-up.

2. Animal Sources

*Animals should be procured from screened, closed herds or colonies that are well-characterized and as free as possible of infectious agents.

*Animals should have documented lineages and be bred and reared in captivity.

*Other outlined issues address the animal facility, including record-keeping, screening for known infectious agents, animal qualifications, and archiving of animal medical records and specimens.

3. Clinical Issues

*The health status of xenotransplant recipients should be monitored clinically and through laboratory tests.

*Laboratory testing methods should be established and documented before the transplant is performed.

*Recipients should be educated concerning potential infectious disease risks to themselves and to their close contacts.

*Hospital infection control procedures should be in place.

*Laboratories should be available to culture and identify both known and novel infectious agents.

*The health-care team should be educated about the possible infectious disease risks.

*Serological samples should be archived for retrospective investigation of possible infections.

*Health-care records should be systematically maintained in ways that protect patients' confidentiality.

4. Public Health Needs

*A national registry is recommended to provide information to assess long-term safety and to help in epidemiological investigations. FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health are collaborating with the Health Resources and Services Administration to develop a pilot program to define the scope, focus, and optimal design of a national registry. Such a registry would help to identify xenotransplant-associated health problems that have public health significance.

 

Source: FDA Backgrounder Web site at http://xenotransplant.ineu.org/xenotrans/19960920.html