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

被引：6

作者：

Adams, Andrew ^{[1
]}

Cendales, Linda C. ^{[2
]}

Cooper, David K. C. ^{[3
]}

Cozzi, Emanuele ^{[4
]}

Gill, John ^{[5
]}

Judd, Eric ^{[6
]}

Katz, Eliezer ^{[7
]}

Kirk, Allan D. ^{[2
]}

Fishman, Jay A. ^{[3
,8
,9
]}

Reese, Peter P. ^{[10
]}

Wall, Anji ^{[11
]}

Markmann, James F. ^{[3
]}

机构：

[1] Univ Minnesota, Dept Surg, Minneapolis, MN USA

[2] Duke Univ, Dept Surg, Durham, NC USA

[3] Massachusetts Gen Hosp, Ctr Transplantat Sci, 55 Fruit St,White 517, Boston, MA 02114 USA

[4] Univ Padua, Dept Cardiothorac & Vasc Surg, Padua, Italy

[5] Univ British Columbia, Dept Med, Vancouver, BC, Canada

[6] Univ Alabama Birmingham, Birmingham, AL USA

[7] eGenesis Bio, Cambridge, MA USA

[8] Harvard Med Sch, Transplant Infect Dis & Compromised Host Program, Boston, MA USA

[9] Harvard Med Sch, MGH Transplant Ctr, Boston, MA USA

[10] Univ Penn, Perelman Sch Med, Ctr Clin Epidemiol & Biostat, Philadelphia, PA USA

[11] Baylor Univ, Med Ctr, Div Abdominal Transplantat, Dallas, TX USA

来源：

AMERICAN JOURNAL OF TRANSPLANTATION | 2023年 / 23卷 / 09期

关键词：

kidney transplant; regulatory; xenotransplantation; PORCINE CYTOMEGALOVIRUS; PIG; COAGULOPATHY; PROTEINURIA; ACTIVATION; INFECTION; REJECTION; SURVIVAL; KIDNEYS; GRAFTS;

D O I：

10.1016/j.ajt.2023.05.010

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

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.

引用

页码：1290 / 1299

页数：10

共 8 条

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Haidar, Ghady
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