Quality control guidelines for clinical-grade human induced pluripotent stem cell lines.

Abstract:

:Use of clinical-grade human induced pluripotent stem cell (iPSC) lines as a starting material for the generation of cellular therapeutics requires demonstration of comparability of lines derived from different individuals and in different facilities. This requires agreement on the critical quality attributes of such lines and the assays that should be used. Working from established recommendations and guidance from the International Stem Cell Banking Initiative for human embryonic stem cell banking, and concentrating on those issues more relevant to iPSCs, a series of consensus workshops has made initial recommendations on the minimum dataset required to consider an iPSC line of clinical grade, which are outlined in this report. Continued evolution of this field will likely lead to revision of these guidelines on a regular basis.

journal_name

Regen Med

journal_title

Regenerative medicine

authors

Sullivan S,Stacey GN,Akazawa C,Aoyama N,Baptista R,Bedford P,Bennaceur Griscelli A,Chandra A,Elwood N,Girard M,Kawamata S,Hanatani T,Latsis T,Lin S,Ludwig TE,Malygina T,Mack A,Mountford JC,Noggle S,Pereira LV,Pric

doi

10.2217/rme-2018-0095

subject

Has Abstract

pub_date

2018-10-01 00:00:00

pages

859-866

issue

7

eissn

1746-0751

issn

1746-076X

journal_volume

13

pub_type

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