Accelerated regulatory pathways are appropriate for any life saving advances as big as xenotransplantation.
Clinical trials are underway now in the US and China and are likely to start in other countries.
The existing oversight for the human donor organ transplant industry offers a very quick path to commercialization as soon as a viable treatment for organ failure is proved.
The dramatic need for organs to transplant ensures an accelerated regulatory approval cycle for a working xenograft for any select population that can benefit.
Clinical trials underway will identify the the patient characteristics for successful xenotransplantation. In the difficult pig to rhesus model that allowed for selection of recipients, more than 1 year survival has been achieved for a xenograft designed for humans. Therefore, it is expected that an organ designed for humans will fare better in a human than a non-human primate.
Early use of xenografts in compassionate use cases has shown physiological compatibility of pig organs in humans and cases where rejection can be reversed. As in transplantation of human organs last century, matching recipients with donors to ensure the highest chance of success should extend xenograft survival considerably.
While estimates to commercialization in the typical pathways is estimated at 3 to 5 years, there is an even more rapid pathway to commercialization available to organs that could allow almost immediate commercialization of early successes.
This super accelerated pathway was created by the 1984 National Organ Transplant Act and was used by the Secretary of HHS to move hand and face transplantation into a clinical service in 2013.
