The use of immunosuppressive drugs and legal implications in xenotransplantation (original) (raw)

2010, Molecular & Cellular Toxicology

Transplantation is recognized as one of the greatest triumphs of modern medical science, but we are confronting the severe shortage of organs for transplantation. Xenotransplantation, the transplantation of nonhuman organs, tissues or cells into humans could be an alternative to fundamentally resolve this problem. Despite the potential benefit, xenotransplantation also gives us a potential risk, which are rejection and infection. The potential immunological rejection means the possibility of the human immune system to reject any foreign object. The rejection mechanism is very similar to that by which the body resists infection. The rejection of foreign object may endanger the life of the recipient. In xenotransplantation, immunosuppressive drugs can be clinically used to prevent the rejection of foreign object. However, these toxic drugs have side effects: the immune system loses its ability to successfully resist infections. The potential risk of infection means xenozoonosis that might result from xenotransplantation. For example, a pig virus, especially PERV might infect the human recipient, mutate and spread first to the close contacts of the recipient and then to the general population. This article primarily focuses on warning the risk of rejection and infection. This article also discusses clinicaltrials, informed consent and legal liability as legal aspects of xenotransplantation. Especially, an in-depth study is further required on legal implications and toxicology of xenotransplantation because the use of immunosuppressants for resolving immune rejection may bring lots of potential toxicologic problems. While clinical trials and informed consent are pretransplant prevention against the potential risk as preconditions for xenotransplantation, legal liability is posttransplant protection from it.

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Ethical and Legal Issues in Xenotransplantation

Bioethics, 2001

In most western countries, there is a`human organ shortage' with waiting lists for the performance of transplantation. In a recent report of the UNOS Ethics Committee it is stated that there are approximately 31,000 potential recipients on waiting lists, but only one fourth of potential donors gave their specific consent. Xenotransplantation ± defined as the transplantation of animal cells, tissues or organs into human beings ± is associated with particular ethical dilemmas, namely the problems of efficiency and safety of this medical procedure. The objective of this study is to analyse the ethical dilemmas in xenotransplantation with the background of a personal view of moral life. Also, xenotransplantation will be evaluated as far as the legal regulation of transplantation is concerned. In particular, we will consider patients rights in accordance with existing laws on organ and tissue transplantation, animal research and clinical trials.

[Ethical aspects of xenotransplantation]

Tidsskrift for den Norske lægeforening : tidsskrift for praktisk medicin, ny række, 2002

The motivation for research on animals as a source of cells, tissues and organs for human transplantation (xenotransplantation) is the scarcity of suitable donors for patients with end-stage organ failure. Use of animals in both experimental and clinical settings raise considerable ethical concerns, especially when non-human primates are used. The pig may represent an acceptable source animal for xenotransplantation and is today regarded as the animal of choice. Xenotransplantation seems defensible from an ethical perspective, but should not be performed in humans until preclinical animal-to-animal xenotransplantations have a predictable rate of success and the risk to society at large is negligible. For the individual patient and his or her next of kin involved, issues of autonomy and proper consent procedures must be given high priority. Safeguards must be established, for the patient and for society at large, in relation to health hazards from infectious organisms, particularly r...

Starting clinical trials of xenotransplantation--reflections on the ethics of the early phase

Journal of Medical Ethics, 2000

What kind of patients may be recruited to early clinical trials of xenotransplantation? This is discussed under the assumption that the risk of viral infection to the public is non-negligible. Furthermore, the conditions imposed by the Helsinki declaration are analysed. The conclusion is that only patients at risk of dying and with no alternative treatment available should be recruited to xenotransplantation trials in the early phase. For some of the less dangerous cell or islet cell xenotransplantation other categories might be recruited. The risk of cell and islet cell xenotransplantation should, however, be weighted against the development of other technologies. In order to safeguard the public, the opt-out clause in the Helsinki declaration should not be fully applied. Legally binding rules on obligatory monitoring and restrictions should be imposed-before clinical trials start.

Position Paper of the Ethics Committee of the International Xenotransplantation Association

Xenotransplantation, 2003

Xenotransplantation (XTx) provides a potential solution to the shortage of human organs and tissues, and has several advantages over other possible solutions to this problem. However, a number of scientific and ethical barriers exist, and need to be addressed in order to advance the field of XTx in a manner that optimizes its potential to benefit society and minimizes its risk. Some of the most pressing ethical issues are discussed, and the position of the Ethics Committee of the International Xenotransplantation Association is presented.

The ethics of xenotransplantation

2002

 Xenotransplantation—moving organs or cells from one species to another—is currently being actively researched as a possible contribution to the problem of a global shortage of human organs for transplants. Should xenotransplantation be encouraged, permitted, frowned upon or forbidden? I attempt to outline the main areas of debate that would need to be addressed before this question could confidently be answered. At present, though, we are some way from answering it.

Ethical rejections of xenotransplantation?

EMBO reports

ene editing and stem cell biotechnologies are being applied to create chimeric animals with human organs, which could alleviate the current shortage of human organs for transplantation. While the medical benefits of xenotransplantation appear to be significant, we discuss specific ethical, medical, cultural, and financial challenges and potential solutions that need to be addressed before clinical trials using organs from human-animal chimeras should begin.

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