TY - JOUR A2 - Lovati, Arianna B. AU - Dias, Rhayra B. AU - Guimarães, João A. M. AU - Cury, Marco B. AU - Rocha, Leonardo R. AU - da Costa, Elaine S. AU - Nogueira, Liebert P. AU - Hochman-Mendez, Camila AU - Fortuna-Costa, Anneliese AU - Silva, Anna Karoline F. AU - Cunha, Karin S. AU - de Souza, Sergio A. L. AU - Duarte, Maria Eugênia L. AU - Sartore, Rafaela C. AU - Bonfim, Danielle C. PY - 2019 DA - 2019/11/07 TI - The Manufacture of GMP-Grade Bone Marrow Stromal Cells with Validated In Vivo Bone-Forming Potential in an Orthopedic Clinical Center in Brazil SP - 2608482 VL - 2019 AB - In vitro-expanded bone marrow stromal cells (BMSCs) have long been proposed for the treatment of complex bone-related injuries because of their inherent potential to differentiate into multiple skeletal cell types, modulate inflammatory responses, and support angiogenesis. Although a wide variety of methods have been used to expand BMSCs on a large scale by using good manufacturing practice (GMP), little attention has been paid to whether the expansion procedures indeed allow the maintenance of critical cell characteristics and potency, which are crucial for therapeutic effectiveness. Here, we described standard procedures adopted in our facility for the manufacture of clinical-grade BMSC products with a preserved capacity to generate bone in vivo in compliance with the Brazilian regulatory guidelines for cells intended for use in humans. Bone marrow samples were obtained from trabecular bone. After cell isolation in standard monolayer flasks, BMSC expansion was subsequently performed in two cycles, in 2- and 10-layer cell factories, respectively. The average cell yield per cell factory at passage 1 was of 21.93 ± 12.81 × 10 6 细胞，而在通路2中，它是的 83.05 ± 114.72 × 10 6 细胞。所有的最终细胞产物是无污染的有氧/厌氧病原体，支原体和细菌内毒素。扩大骨髓基质干细胞表达CD73，CD90，CD105，CD146和并能分化为成骨细胞，软骨细胞，在体外脂肪细胞谱系。最重要的是，当体内移植九的细胞产物形成的骨的10。这些验证程序，将作为内部BMSC制造用于在我们中心的临床应用奠定了基础。SN - 1687-966X UR - https://doi.org/10.1155/2019/2608482 DO - 10.1155 /二百六十〇万八千四百八十二分之二千○十九JF - 干细胞国际PB - Hindawi出版KW - ER -