Embryonic Stem Cell Laboratories, Guy's Assisted Conception Unit, Division of Reproduction and Endocrinology, King's College London, London, UK.
J R Soc Interface. 2010 Dec 6;7 Suppl 6(Suppl 6):S677-88. doi: 10.1098/rsif.2010.0343.focus. Epub 2010 Sep 8.
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.
干细胞在再生医学中的应用引起了公众的想象，媒体的关注也导致了人们对临床获益的期望不断提高。人类胚胎干细胞（hESC）是干细胞治疗中资本投资的最佳模型，在为此目的大规模扩大细胞扩增之前，需要对其进行稳健的遗传特征分析。我们必须确保起始材料的基因组稳定且正常，但传统核型分析的分辨率有限，无法提供这种保证。先进的分子细胞遗传学技术，如用于识别染色体不平衡的阵列比较基因组杂交，以及用于识别种族背景和杂合性丢失的单核苷酸多态性分析，应在每个新衍生的 hESC 系被存入国家干细胞库之前，作为强制性诊断测试引入。如果像我们在这里提议的那样，这个新的质量标准成为一个要求，那么它将促进和加速银行的进程，因为最终用户将能够为他们的特定应用选择最合适的系，从而提高效率并简化制造治疗药物的途径。制药行业可能会使用 hESC 衍生的细胞进行药物筛选，但不应忽略它们的基因组特征，因为这可能会导致对结果的错误解释和资源的大量浪费。
