Xenotransplantation: regulatory challenges

被引：9

作者：

Bloom, ET ^{[1
]}

机构：

[1] US FDA, Ctr Biol Evaluat & Res, Div Cellular & Gene Therapies, Rockville, MD 20852 USA

来源：

CURRENT OPINION IN BIOTECHNOLOGY | 2001年 / 12卷 / 03期

关键词：

D O I：

10.1016/S0958-1669(00)00218-4

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

During 1999-2000, the US government published three xenotransplantation policy/guidance documents, one by the Public Health Service and two by the Food and Drug Administration (FDA). The FDA also held two public meetings of the xenotransplantation subcommittee of the Biological Response Modifiers Advisory Committee to discuss particular issues in xenotransplantation.

引用

页码：312 / 316

页数：5

共 21 条

[1]

[Anonymous], 1993, FED REG

[2] Physiologic incompatibilities in discordant xenotransplantation [J].

Breimer, ME .

TRANSPLANTATION PROCEEDINGS, 1999, 31 (1-2) :905-908

[3] Xenogeneic infections and public health [J].

Chapman, LE .

CLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, 1999, 26 (12) :1005-1008

[4]

Chen SC, 1997, ANN NY ACAD SCI, V831, P350

[5]

Dapolito Gail, 2000, Xenotransplantation, V7, P75

[6]

*FDA, 2001, DRAFT GUID IND SOURC

[7] Porcine xenografts in parkinson's disease and Huntington's disease patients: Preliminary results [J].

Fink, JS ;

Schumacher, JM ;

Ellias, SL ;

Palmer, EP ;

Saint-Hilaire, M ;

Shannon, K ;

Penn, R ;

Starr, P ;

VanHorne, C ;

Kott, HS ;

Dempsey, PK ;

Fischman, AJ ;

Raineri, R ;

Manhart, C ;

Dinsmore, J ;

Isacson, O .

CELL TRANSPLANTATION, 2000, 9 (02) :273-278

[8] Xenotransplantation - 2000 [J].

Goddard, MJ ;

Foweraker, JE ;

Wallwork, J .

JOURNAL OF CLINICAL PATHOLOGY, 2000, 53 (01) :44-48

[9]

Institute of Medicine, 1996, XEN SCI ETH PUBL POL

[10] Discordant organ xenotransplantation in primates - World experience and current status [J].

Lambrigts, D ;

Sachs, DH ;

Cooper, DKC .

TRANSPLANTATION, 1998, 66 (05) :547-561

← 1 2 3 →