Document Detail


The Generation of Six Clinical-Grade Human Embryonic Stem Cell Lines.
MedLine Citation:
PMID:  18371388     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The edict for producing clinically compliant human embryonic stem cells (hESCs) necessitates adherence to global ethical standards for egg procurement and embryo donation, conformity to regulations controlling clinical-grade cell and tissue product development, and compliance with current good tissue and manufacturing practices (cGTPs and cGMPs, respectively). For example, the U.S. FDA Center for Biologics Evaluation and Research recently promulgated regulations regarding human cells and cellular-based products (HCT/Ps) intended for tissue repair or replacement. Issued under Code of Federal Regulations parts 1270 and 1271 (Code of Federal Regulations, 2006a, 2006b), the rules are broadened by requirements for donor selection and cGMPs for HCT/Ps. By adhering to regulations and in anticipation of future standards, we have generated six clinical-grade hESC lines. Here we describe their manufacture, from embryo procurement to line characterization, including sterility and pathogen testing (Figure 1). To our knowledge, the lines represent the first to have been produced in compliance with international regulatory requirements, suitable for therapeutic use.
Authors:
Jeremy Micah Crook; Teija Tuulikki Peura; Lucy Kravets; Alexis Gina Bosman; Jeremy James Buzzard; Rachel Horne; Hannes Hentze; Norris Ray Dunn; Robert Zweigerdt; Florence Chua; Alan Upshall; Alan Colman
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Publication Detail:
Type:  LETTER    
Journal Detail:
Title:  Cell stem cell     Volume:  1     ISSN:  1875-9777     ISO Abbreviation:  Cell Stem Cell     Publication Date:  2007 Nov 
Date Detail:
Created Date:  2008-3-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101311472     Medline TA:  Cell Stem Cell     Country:  -    
Other Details:
Languages:  ENG     Pagination:  490-494     Citation Subset:  -    
Affiliation:
ES Cell International Pte Ltd., Singapore 138667.
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