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首页> 美国卫生研究院文献>Scientific Reports >Manufacturing Differences Affect Human Bone Marrow Stromal Cell Characteristics and Function: Comparison of Production Methods and Products from Multiple Centers
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Manufacturing Differences Affect Human Bone Marrow Stromal Cell Characteristics and Function: Comparison of Production Methods and Products from Multiple Centers

机译：制造差异影响人骨髓基质细胞特性和功能：来自多个中心的生产方法和产品的比较

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Human bone marrow stromal cells (BMSCs, also known as bone marrow-derived mesenchymal stem cells) are manufactured using many different methods, but little is known about the spectrum of manufacturing methods used and their effects on BMSC characteristics and function. Seven centers using, and one developing, Good Manufacturing Practices (GMP) processes were surveyed as to their production methods. Among the seven centers, all used marrow aspirates as the starting material, but no two centers used the same manufacturing methods. Two to four BMSC lots from each center were compared using global gene expression. Among the twenty-four BMSC lots from the eight centers intra-center transcriptome variability was low and similar among centers. Principal component analysis and unsupervised hierarchical clustering analysis separated all the lots from five centers into five distinct clusters. BMSCs from six of the eight centers were tested for their ability to form bone and support hematopoiesis by in vivo transplantation (defining features of BMSCs). Those from all six centers tested formed bone, but the quantity formed was highly variable and BMSCs from only three centers supported hematopoiesis. These results show that differences in manufacturing resulted in variable BMSC characteristics including their ability to form bone and support hematopoiesis.
机译：人骨髓基质细胞（BMSC，也称为骨髓间充质干细胞）是用许多不同的方法制造的，但对于所用制造方法的种类及其对BMSC特性和功能的影响知之甚少。调查了七个使用并正在开发良好生产规范（GMP）流程的中心的生产方法。在这七个中心中，所有中心都使用骨髓吸出液作为起始原料，但是没有两个中心使用相同的制造方法。使用全局基因表达比较每个中心的2至4个BMSC批次。在来自八个中心的二十四个BMSC批次中，中心内转录组变异性较低，并且中心之间相似。主成分分析和无监督的层次聚类分析将来自五个中心的所有批次分为五个不同的聚类。通过体内移植测试了八个中心中六个中心的BMSC形成骨和支持造血的能力（定义了BMSC的特征）。来自所有六个中心的受检者均形成了骨骼，但形成的数量变化很大，只有三个中心的BMSC支持造血。这些结果表明，制造差异会导致可变的BMSC特性，包括其形成骨骼和支持造血功能。

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