ヒトES細胞の標準化 Identity 同一性

Guideline on human cell-based medicinal products by EMEA

London, 11 January 2007,

Doc. Ref. EMEA/CHMP/410869/2006

Identity

1. Cellular component

1.1 Phenotypic profiles

1.1.1 Relevant markers 

1.1.1.1 Gene expression

Oct-4/3, Nanog, Sox2

1.1.1.2 Biochemical activity

Alkaline phosphatase

1.1.1.3 Antigen presentation

Tra-1-60, Tra-1-81, 6E2, SSEA-3/4

1.1.1.4 Protein expression

Oct-4/3, Nanog, Sox2, E-cadherin: Present

T, Pax6, AFP: absent.

1.1.1.4 Response to exogenous stimuli (FGF dependence)

1.1.1.5 Capability to produce measurable molecules

1.1.2 Morphology

1.1.3 Growth (Population doubling time: up to 36 h)

1.2 Genotypic profiles

1.2.1Short tandem repeat.

1.2.2 HLA

1.2.3 Karyotype

1.2.3 Other genetic markers

2. Differentiation

2.1 in vitro differentiation (EB formation, etc)

2.2 Teratoma formation

3. Contamination

3.1 Bacteria, fungus, virus, yeast, mycoplasma.

3.2 Cells

他　参考文献

Carpenter, MK, et al., Developing safe therapies from pluripotent stem cells, Nat Biotechnol, 27(7):606, 2009.

胚性幹（ES）細胞臨床指針作成に向けた課題検討のための予備研究、平成19年度　総括研究報告書、主任研究者　中内啓光　分担研究者　梅澤明弘　p155

 

日本におけるヒトES、iPS細胞研究標準化：その１、古江ー楠田　美保、Tiss. Cult. Res. Commun. 27:139-147, 2008.

Andrews, PW, et al., The International Stem Cell Initiative: toward benchmarks for human embryonic stem cell lines. Nat Biotechnol, 23: 795, 2005.

Adewumi, O., et al., Characterization and culture of human embryonic stem cell lines by the International Stem Cell Initiative. Nat Biotechnol, 2007.