Aizman Irina, Holland William S, Yang Cher, Bates Damien
Department of Research, SanBio, Inc. , Mountain View, CA , USA.
Department of Research, SanBio, Inc., Mountain View, CA, USA; †Clinical Development and Regulatory Affairs, SanBio, Inc., Mountain View, CA, USA.
Cell Med. 2016 Oct 6;8(3):79-85. doi: 10.3727/215517916X693357. eCollection 2016 Dec 3.
Clinical applications of mesenchymal stromal cells (MSCs) require the manufacture of large cell lots, which involves multiple passages for cell expansion and sometimes genetic modification. MSCs from various sources, including bone marrow (BM), exhibit high donor-to-donor variability in their growth characteristics. This can lead to unpredictable manufacturing outcomes with respect to success or failure of individual lots. Early determination of lot success has the potential to reduce the cost and improve the efficiency of the MSC manufacturing process. However, methods that effectively predict lot growth potential early in the manufacturing process are currently lacking. Here we report that the growth potential of an MSC lot can be predicted a few days after BM plating based on α-smooth muscle actin (αSMA) protein expression in large colony-forming unit-fibroblast (CFU-f) colonies. The proposed prediction method could be a useful tool to prospectively determine MSC lot success or failure.
间充质基质细胞（MSC）的临床应用需要大量细胞的制备，这涉及到多次传代以进行细胞扩增，有时还需要进行基因改造。来自包括骨髓（BM）在内的各种来源的MSC，其生长特性在供体之间表现出高度变异性。这可能导致各个批次在制备结果上的成功或失败不可预测。早期确定批次是否成功有潜力降低成本并提高MSC制备过程的效率。然而，目前缺乏在制备过程早期有效预测批次生长潜力的方法。在此，我们报告基于大集落形成单位成纤维细胞（CFU-f）集落中α平滑肌肌动蛋白（αSMA）蛋白表达，在BM接种几天后就可以预测MSC批次的生长潜力。所提出的预测方法可能是一种前瞻性确定MSC批次成功或失败的有用工具。
