Assessing the Safety of Stem Cell Therapeutics

被引：190

作者：

Goldring, Chris E. P. ^{[1
]}

Duffy, Paul A. ^{[2
]}

Benvenisty, Nissim ^{[3
,4
]}

Andrews, Peter W. ^{[5
]}

Ben-David, Uri ^{[3
]}

Eakins, Rowena ^{[1
]}

French, Neil ^{[1
]}

Hanley, Neil A. ^{[6
]}

Kelly, Lorna ^{[1
]}

Kitteringham, Neil R. ^{[1
]}

Kurth, Jens ^{[7
]}

Ladenheim, Deborah ^{[8
]}

Laverty, Hugh ^{[1
]}

McBlane, James ^{[9
]}

Narayanan, Gopalan ^{[9
]}

Patel, Sara ^{[10
]}

Reinhardt, Jens ^{[11
]}

Rossi, Annamaria ^{[12
]}

Sharpe, Michaela ^{[12
]}

Park, B. Kevin ^{[1
]}

机构：

[1] Univ Liverpool, Inst Translat Med, Div Mol & Clin Pharmacol, MRC Ctr Drug Safety Sci, Liverpool L69 3GE, Merseyside, England

[2] Safety Assessment UK, AstraZeneca R&D Alderley Pk, Macclesfield SK10 4TG, Cheshire, England

[3] Hebrew Univ Jerusalem, Inst Life Sci, Dept Genet, Stem Cell Unit, IL-91904 Jerusalem, Israel

[4] Cedars Sinai Med Ctr, Regenerat Med Inst, Los Angeles, CA 90048 USA

[5] Univ Sheffield, Dept Biomed Sci, Ctr Stem Cell Biol, Sheffield S10 2TN, S Yorkshire, England

[6] Univ Manchester, Manchester Acad Hlth Sci Ctr, Endocrinol & Diabet Grp, Manchester M13 9PT, Lancs, England

[7] Novartis Pharma AG, CH-4056 Basel, Switzerland

[8] Athersys, Cleveland, OH 44115 USA

[9] Med & Healthcare Prod Regulatory Agcy MHRA, London SW1W 9SZ, England

[10] ReNeuron Ltd, Surrey GU2 7AF, England

[11] Paul Ehrlich Inst, D-63225 Langen, Germany

[12] Pfizer Ltd, Sandwich Labs, Drug Safety Res & Dev, Sandwich CT13 9NJ, Kent, England

来源：

CELL STEM CELL | 2011年 / 8卷 / 06期

基金：

英国医学研究理事会; 英国惠康基金;

关键词：

FUNCTIONAL-PROPERTIES; HEPATIC ENDODERM; FDA REGULATION; COPY NUMBER; SERUM-FREE; IN-VITRO; DIFFERENTIATION; GENERATION; TUMORIGENICITY; IMMUNOGENICITY;

D O I：

10.1016/j.stem.2011.05.012

中图分类号：

Q813 [细胞工程];

学科分类号：

摘要：

Unprecedented developments in stem cell research herald a new era of hope and expectation for novel therapies. However, they also present a major challenge for regulators since safety assessment criteria, designed for conventional agents, are largely inappropriate for cell-based therapies. This article aims to set out the safety issues pertaining to novel stem cell-derived treatments, to identify knowledge gaps that require further research, and to suggest a roadmap for developing safety assessment criteria. It is essential that regulators, pharmaceutical providers, and safety scientists work together to frame new safety guidelines, based on "acceptable risk," so that patients are adequately protected but the safety "bar" is not set so high that exciting new treatments are lost.

引用

页码：618 / 628

页数：11

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