Xenotransplantation - Tissue - live donors

Also known as: xenografts

Essential information

Definition/s

Xenotransplantation: any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a non-human animal source, or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live, non-human animal cells, tissues, or organs. Xenotransplantation products include live cells, tissues and organs.

Biological products, drugs, or medical devices sourced from non-living cells, tissues or organs from non-human animals, including but not limited to porcine insulin, porcine heart valves, and collagen matrices derived from acellular porcine, bovine or any other xenogeneic source (e.g. PelviSoft®, Bio-Oss®, Bio-Gide® and Surgibone®) are not considered xenotransplantation products.

Includes

Xenografts, heterografts, non-human organ perfusion.

Scenarios

Xenotransplant recipient

Obligatory

Must not donate if:

Material from a living non-human animal source has been directly or indirectly in contact with the donor's blood supply. This does not include animal bites.

Current or former sexual partner of a xenotransplant recipient

Obligatory

Must not donate.

Additional information

Exposure to non-human animal material, particularly when the person exposed is immunosuppressed, may result in infections that would not normally affect humans being passed on.

Supporting information

Regulatory information

This advice is a requirement of the EU Tissue and Cells Directive.

Reason for change:

Further guidance re Recipient definition.

Version details:

TL-DSG Edition 203 Release 25 (13 July 2016)