The paper presents issues that shall be considered and elaborated before xenotransplantation reaches clinical stage. In a scope of a research project, such considerations as rules and procedures of a donor selection, including nature of its genetic modifications, must be undertaken. Another problem are regulatory requirements concerning pre-clinical tests on primates. Detailed conditions and requirements that must be fulfilled before clinical trials start are also discussed in the paper. Patient selection criteria as well as relationship with him/her before and after transplantation shall be clarified. A matter of high importance are organisational guidelines and relevant legal aspects of donor animals, breeding and xenotransplantation product harvesting, as well as ethical dimension of these actions.