Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy

被引：35

作者：

Rehakova, Daniela ^{[1
,2
]}

Souralova, Tereza ^{[2
,3
]}

Koutna, Irena ^{[2
,3
]}

机构：

[1] Masaryk Univ, Fac Sci, Dept Expt Biol, Kamenice 5, Brno 62500, Czech Republic

[2] St Annes Univ Hosp Brno, Int Clin Res Ctr, Pekarska 53, Brno 65691, Czech Republic

[3] Masaryk Univ, Fac Med, Dept Histol & Embryol, Kamenice 3, Brno 62500, Czech Republic

来源：

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES | 2020年 / 21卷 / 07期

关键词：

hPSCs; human pluripotent stem cells; characterization; hESC; human embryonic stem cells; hiPSC; human induced pluripotent stem cells; clinical; cGMP; cell therapy; GOOD MANUFACTURING PRACTICE; LINES; DIFFERENTIATION; BANKING; REVEALS; CULTURE; NUMBER; DONOR; FIBROBLASTS; GENERATION;

D O I：

10.3390/ijms21072435

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

Human pluripotent stem cells have the potential to change the way in which human diseases are cured. Clinical-grade human embryonic stem cells and human induced pluripotent stem cells have to be created according to current good manufacturing practices and regulations. Quality and safety must be of the highest importance when humans' lives are at stake. With the rising number of clinical trials, there is a need for a consensus on hPSCs characterization. Here, we summarize mandatory and ' for information only ' characterization methods with release criteria for the establishment of clinical-grade hPSC lines.

引用

页数：14

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