In June 2022, the US Food and Drug Administration Center for Biologics Evaluation and

Research held the 73rd meeting of the Cellular, Tissue, and Gene Therapies Advisory

Committee for public discussion of regulatory expectations for xenotransplantation products.

The members of a joint American Society of Transplant Surgeons/American Society of

Transplantation committee on xenotransplantation compiled a meeting summary focusing on 7 topics believed to be key by the committee: 

(1) preclinical evidence supporting progression to a clinical trial, 

(2) porcine kidney function, 

(3) ethical aspects, 

(4) design of initial clinical trials, 

(5) infectious disease issues, 

(6) industry perspectives

(7) regulatory oversight