New Regulations Needed For Patients Receiving Animal Tissue Donation - Study Recommends Patient Waivers That Provide Full Disclosure Of Risks

Main Category: Transplants / Organ Donations
Also Included In: Public Health
Article Date: 28 Jun 2007 - 13:00 PDT

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A new article in The Journal of Law, Medicine and Ethics calls for a change in the regulations surrounding xenotransplantation, the transplanting of animal cells, tissues or organs into humans. Although few xenotransplantation procedures have been done to this time, there appears to be a lack of awareness among potential xenotransplant patients about the risk of the procedures, and the required lifetime of infectious disease monitoring that come with it.

"When animal cells are transplanted into a human, there is always a risk of new diseases emerging, which is why the federal government requires that a recipient must always be monitored long-term," says Dr. Monique Spillman, co-author of the study. "Patients should be aware of the realities of life after the transplant before they make any decisions."

This issue has become particularly urgent recently, due to the theoretical risk that stem cell trials may involve human cell lines that have been in contact with animal tissue. Although the stem cells are human, they have to be subject to xenotransplant surveillance protocols due to contact with animal tissues in the laboratory.

"While patients may be excited about these new therapies, they may not be aware that under the current federal regulations, the recipient of a xenotransplant must submit to lifelong surveillance for infectious diseases, even if the animal organ or tissue is removed," says Spillman. The authors suggest that patients deciding whether or not to receive animal tissue should be provided with a "Ulysses contract," which requires the patient to agree to lifetime surveillance if a xenotransplant is done. In accepting the contract, the patient, in essence, waives a basic right, the right to refuse follow-up testing.

Ultimately, the goal is to provide patients with the most informed choices while still protecting public health. "Potential recipients would have the options to accept the contract, to decline the contract and wait for a traditional transplant, or to accept the consequences of their end-organ failure," says Spillman, "but most importantly, they would be selecting the option that best fits their situation and desires."

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