American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products

Andrew Adams; Linda C Cendales; David K C Cooper; Emanuele Cozzi; John Gill; Eric Judd; Eliezer Katz; Allan D Kirk; Jay A Fishman; Peter P Reese; Anji Wall; James F Markmann

doi:10.1016/j.ajt.2023.05.010

American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products

Am J Transplant. 2023 Sep;23(9):1290-1299. doi: 10.1016/j.ajt.2023.05.010. Epub 2023 May 20.

Authors

Andrew Adams¹, Linda C Cendales², David K C Cooper³, Emanuele Cozzi⁴, John Gill⁵, Eric Judd⁶, Eliezer Katz⁷, Allan D Kirk², Jay A Fishman⁸, Peter P Reese⁹, Anji Wall¹⁰, James F Markmann¹¹

Affiliations

¹ Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
² Department of Surgery, Duke University, Durham, North Carolina, USA.
³ Center for Transplantation Sciences, Massachusetts General Hospital, Boston, Massachusetts, USA.
⁴ Department of Cardiothoracic and Vascular Surgery, University of Padua, Padua, Italy.
⁵ Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
⁶ University of Alabama at Birmingham, Birmingham, Alabama, USA.
⁷ eGenesis Bio, Cambridge, Massachusetts, USA.
⁸ Center for Transplantation Sciences, Massachusetts General Hospital, Boston, Massachusetts, USA; Transplant Infectious Disease and Compromised Host Program and MGH Transplant Center, Harvard Medical School, Boston, Massachusetts, USA.
⁹ Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
¹⁰ Division of Abdominal Transplantation, Baylor University Medical Center, Dallas, Texas, USA.
¹¹ Center for Transplantation Sciences, Massachusetts General Hospital, Boston, Massachusetts, USA. Electronic address: jmarkmann@partners.org.

PMID: 37217005
DOI: 10.1016/j.ajt.2023.05.010

Abstract

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, and (7) regulatory oversight.

Keywords: kidney transplant; regulatory; xenotransplantation.

MeSH terms

Animals
Humans
Motivation*
Surgeons*
Swine
Transplantation, Heterologous
United States
United States Food and Drug Administration