title: Safety paradigm: genetic evaluation of therapeutic grade human embryonic stem cells.
abstract: The use of stem cells for regenerative medicine has captured the imagination of the public, with media attention contributing to rising expectations of clinical benefits. Human embryonic stem cells (hESCs) are the best model for capital investment in stem cell therapy and there is a clear need for their robust genetic characterization before scaling-up cell expansion for that purpose. We have to be certain that the genome of the starting material is stable and normal, but the limited resolution of conventional karyotyping is unable to give us such assurance. Advanced molecular cytogenetic technologies such as array comparative genomic hybridization for identifying chromosomal imbalances, and single nucleotide polymorphism analysis for identifying ethnic background and loss of heterozygosity should be introduced as obligatory diagnostic tests for each newly derived hESC line before it is deposited in national stem cell banks. If this new quality standard becomes a requirement, as we are proposing here, it would facilitate and accelerate the banking process, since end-users would be able to select the most appropriate line for their particular application, thus improving efficiency and streamlining the route to manufacturing therapeutics. The pharmaceutical industry, which may use hESC-derived cells for drug screening, should not ignore their genomic profile as this may risk misinterpretation of results and significant waste of resources.
authors.affiliation: Embryonic Stem Cell Laboratories, Guy's Assisted Conception Unit, Division of Reproduction and Endocrinology, King's College London, London, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: Stephenson
authors.forename: Caroline Mackie
authors.initials: CM
authors.lastname: Ogilvie
authors.forename: Heema
authors.initials: H
authors.lastname: Patel
authors.forename: Glenda
authors.initials: G
authors.lastname: Cornwell
authors.forename: Laureen
authors.initials: L
authors.lastname: Jacquet
authors.forename: Neli
authors.initials: N
authors.lastname: Kadeva
authors.forename: Peter
authors.initials: P
authors.lastname: Braude
authors.forename: Dusko
authors.initials: D
authors.lastname: Ilic
mesh_terms: D018929:Cell Culture Techniques; D055028:Comparative Genomic Hybridization; D046149:Embryo Culture Techniques; D004622:Embryo, Mammalian / Q000166:cytology; D053595:Embryonic Stem Cells / Q000166:cytology / Q000637:transplantation*; D042822:Genomic Instability; D006801:Humans; D007621:Karyotyping; D020641:Polymorphism, Single Nucleotide; D044968:Regenerative Medicine / Q000592:standards*
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