The derivation of clinical-grade human embryonic stem cell lines

Edited by Horst Feldmann

Received 21 March 2006; accepted 22 March 2006. published online 07 April 2006.

Abstract

The pluripotent nature of human embryonic stem cells (hESC) has attracted great interest in using them as a source of cells or tissue in cell therapy. However, in order to be used in regenerative medicine, the pluripotent hESC lines should be established and propagated according to good manufacturing practice quality requirements. The cultures should be animal substance free in order to exclude the risk of infections and immunogenity. They should also be genetically and epigenetically normal. The detailed molecular mechanisms of their pluripotency are still not defined. Using human feeder cells, a medium containing only human proteins, the mechanical isolation of the inner cell mass and mechanical passaging of hESC, is a safe option until a functional defined medium containing physiological concentrations of regulatory factors is available.

Keywords: Human embryonic stem cells, Derivation, Culture, Good manufacturing practice

Abbreviations: hESC, human embryonic stem cells, GMP, good manufacturing practice, ICM, inner cell mass, FBS, fetal calf serum, SR, serum replacement, ECM, extracellular matrix, IVF, in vitro fertilization

a Institute of Regenerative Medicine, Regea, University of Tampere and Tampere University Hospital, FI 33520 Tampere, Finland

b Department of Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, SE 141 86 Stockholm, Sweden

c Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital Huddinge K 57, SE 141 86 Stockholm, Sweden

Corresponding author. Fax: +46 8 58587575.

PII: S0014-5793(06)00410-8

doi:10.1016/j.febslet.2006.03.083

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