Xenotransplantation

“sponsors have important responsibilities in terms of documenting information relating to the xenotransplantation product and procedure, for recipient monitoring and follow-up, and for collection and storage of archival tissue samples from animal source and recipient. Assessment of proposed clinical trials involving xenotransplantation requires GTAC to assess data on source animal and xenotransplantation product characterisation, preclinical data, patient selection, medical procedures to be undertaken, plans for post-transplant patient monitoring, and the qualifications and experience of professionals involved in patient care, the animal facility and animal-testing laboratories.”

With regards to deriving xenografts from source animals, the …show more content…
In particular, if a xenotransplantation product known to harbour an infectious agent is used, active screening for that infectious agent should be implemented (e.g. assess all recipients of xenotransplantation products involving the use of porcine products for evidence of infection by PERV)
4) Provide a plan for post-mortem detection of infectious agents and archiving of autopsy samples

The screening program should extend for the life of the patient, although frequency of follow-up may decrease with the length of time post …show more content…
Where a serious adverse event occurs, the sponsor of the trial is obligated to report it to Medsafe within 72 hours of being informed of the adverse events. Simultaneously to recording information on recipients, animal facilities should also record animal health events such as any breaks in the environmental barriers of the secured animal facility, disease outbreaks and any sudden, unexplained or unexpected animal deaths. The animal facility should report animal health events to the sponsor who should include this information in its tracking system for recipients and in reports to the Ministry of