Clinical xenotransplantation.

Infectious disease issues in xenotransplantation.

Xenotransplantation, the transplantation of living organs, tissues, or cells from one species to another, is viewed as a potential solution to the existing shortage of human organs for transplantation. While whole-organ xenotransplantation is still in the preclinical stage, cellular xenotransplantation and extracorporeal perfusion applications are showing promise in early clinical trials. Advan...

First WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials: Changsha, China, 19-21 November 2008. The Changsha Communiqué.

O-17: Human Ovarian Tissue Xenotransplantation Application in Drug Discover

Background: Reproductive toxicity studies (RTS) represent an important part of pre-clinical safety evaluation of any drug development process for human consumption. It is mandatory requirement that RTS must be completed before any drug can be administered to women of childbearing age. Therefore, at first segment of toxicity check the toxic effect of the drug on fertility must be tested on non-c...

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

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 xenot...

Regulation of Clinical Xenotransplantation-Time for a Reappraisal.

The continual critical shortage of organs and cells from deceased human donors has stimulated research in the field of cross-species transplantation (xenotransplantation), with the pig selected as the most suitable potential source of organs. Since the US Food and Drug Administration concluded a comprehensive review of xenotransplantation in 2003, considerable progress has been made in the expe...

Personal and social effects of xenotransplantation

9.1 A health care system is part of a wider social order. Developments in health care cannot, therefore, be separated from their social context and the broader effects they may have. It is difficult to predict how social attitudes and institutions will respond to xenotransplantation, should it become introduced as a clinical treatment. It is important to consider what these responses might be, ...