Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
Department of Orthopaedic Surgery, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan.
Int J Mol Sci. 2022 Jan 18;23(3):1017. doi: 10.3390/ijms23031017.
Extracellular vesicles (EVs) released by bone marrow stromal cells (BMSCs) have been shown to act as a transporter of bioactive molecules such as RNAs and proteins in the therapeutic actions of BMSCs in various diseases. Although EV therapy holds great promise to be a safer cell-free therapy overcoming issues related to cell therapy, manufacturing processes that offer scalable and reproducible EV production have not been established. Robust and scalable BMSC manufacturing methods have been shown to enhance EV production; however, the effects on EV quality remain less studied. Here, using human BMSCs isolated from nine healthy donors, we examined the effects of high-performance culture media that can rapidly expand BMSCs on EV production and quality in comparison with the conventional culture medium. We found significantly increased EV production from BMSCs cultured in the high-performance media without altering their multipotency and immunophenotypes. RNA sequencing revealed that RNA contents in EVs from high-performance media were significantly reduced with altered profiles of microRNA enriched in those related to cellular growth and proliferation in the pathway analysis. Given that pre-clinical studies at the laboratory scale often use the conventional medium, these findings could account for the discrepancy in outcomes between pre-clinical and clinical studies. Therefore, this study highlights the importance of selecting proper culture conditions for scalable and reproducible EV manufacturing.
骨髓基质细胞(BMSCs)释放的细胞外囊泡(EVs)已被证明在 BMSCs 治疗各种疾病的治疗作用中充当生物活性分子(如 RNA 和蛋白质)的转运体。尽管 EV 治疗有望成为一种更安全的无细胞治疗方法,可以克服与细胞治疗相关的问题,但尚未建立可提供可扩展和可重复 EV 生产的制造工艺。已经证明,强大且可扩展的 BMSC 制造方法可提高 EV 的生产,但对 EV 质量的影响研究较少。在这里,我们使用从九位健康供体中分离的人 BMSCs,研究了能够快速扩增 BMSC 的高性能培养基对 EV 生产和质量的影响,与传统培养基相比。我们发现,在高性能培养基中培养的 BMSC 的 EV 产量显著增加,而其多能性和免疫表型不变。RNA 测序显示,来自高性能培养基的 EV 中的 RNA 含量显著降低,通路分析中与细胞生长和增殖相关的 miRNA 谱发生改变。鉴于实验室规模的临床前研究通常使用传统培养基,这些发现可能解释了临床前和临床研究结果之间的差异。因此,本研究强调了为可扩展和可重复的 EV 制造选择适当培养条件的重要性。