Stultz Brian G, McGinnis Kathleen, Thompson Elaine E, Lo Surdo Jessica L, Bauer Steven R, Hursh Deborah A
Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Cytotherapy. 2016 Mar;18(3):336-43. doi: 10.1016/j.jcyt.2015.11.017. Epub 2016 Jan 15.
Mesenchymal stromal cells (MSCs) are being investigated for use in cell therapy. The extensive in vitro expansion necessary to obtain sufficient cells for clinical use increases the risk that genetically abnormal cells will arise and be propagated during cell culture. Genetic abnormalities may lead to transformation and poor performance in clinical use, and are a critical safety concern for cell therapies using MSCs.
We used spectral karyotyping (SKY) to investigate the genetic stability of human MSCs from ten donors during passaging.
Our data indicate that chromosomal abnormalities exist in MSCs at early passages and can be clonally propagated. The karyotypic abnormalities observed during our study diminished during passage.
Karyotyping of MSCs reveals characteristics which may be valuable in deciding the suitability of cells for further use. Karyotypic analysis is useful for monitoring the genetic stability of MSCs during expansion.
正在研究间充质基质细胞（MSC）用于细胞治疗。为获得足够的细胞用于临床使用而进行的广泛体外扩增增加了在细胞培养过程中出现并增殖基因异常细胞的风险。基因异常可能导致细胞转化以及临床使用中的不良表现，并且是使用MSC的细胞治疗的关键安全问题。
我们使用光谱核型分析（SKY）来研究来自十位供体的人MSC在传代过程中的遗传稳定性。
我们的数据表明，早期传代的MSC中存在染色体异常，并且这些异常可以克隆性增殖。在我们的研究中观察到的核型异常在传代过程中减少。
MSC的核型分析揭示的特征可能对决定细胞是否适合进一步使用具有重要价值。核型分析对于监测MSC在扩增过程中的遗传稳定性很有用。
