通过离心外周血获得的富含血小板的血浆由于其丰富的生长因子而可以促进成骨，但也有缺点，包括生长因子快速流失以及取决于供体因素的效果不一致。为了克服这些问题，我们在世界上第一个使用冻干的人诱导多能干细胞来源的巨核细胞和血小板（S-FD-iMP），并发现它们具有促进成骨的作用。由于发现湍流可以激活血小板生物发生，并且现在可以通过一种名为 VerMES 的设备在临床规模上生产 iPS 细胞衍生的血小板，因此本研究检查了临床规模 FD-iMP（V-FD- iMP）用于未来的人类临床应用。我们将 S-FD-iMP、V-FD-iMP 或盐水与人造骨一起注射到 8 周龄雄性 Sprague-Dawley 大鼠的腰椎（每只 n = 4）并通过计算机断层扫描（CT）和病理学评估骨形成。接下来，我们将 V-FD-iMP 或盐水与人造骨一起注射到 5 周大的雄性新西兰白兔（每只 n = 4）的腰椎上，并通过 CT 和病理学评估骨形成。在腰椎中接受人造骨和 V-FD-iMP 的大鼠 (n = 10) 和兔子 (n = 6) 还观察了 6 个月的不良事件，包括感染、肿瘤形成和死亡。术后8周，与对照组相比，iMPs和S-FD-iMPs显着增强了大鼠腰椎的成骨作用，但它们之间没有显着差异。此外，术后 8 周，V-FD-iMP 大力促进兔子腰椎的成骨。在大鼠和兔子中，V-FD-iMP 在 6 个月内没有显示出任何副作用，包括感染、肿瘤形成和死亡。这些结果表明 V-FD-iMP 可以促进安全的成骨。© 2024 日本再生医学会。由 Elsevier B.V. 出版

Platelet-rich plasma obtained by centrifuging peripheral blood can promote osteogenesis owing to its abundant growth factors but has drawbacks, including rapid growth factor loss and inconsistent effects depending on donor factors. To overcome these issues, we were the first in the world to use freeze-dried human induced pluripotent stem cell-derived megakaryocytes and platelets (S-FD-iMPs) and found that they have osteogenesis-promoting effects. Since turbulence was found to activate platelet biogenesis and iPS cell-derived platelets can now be produced on a clinical scale by a device called VerMES, this study examined the osteogenesis-promoting effect and safety of clinical-scale FD-iMP (V-FD-iMPs) for future human clinical application.We administered either S-FD-iMPs, V-FD-iMPs, or saline along with artificial bone to the lumbar spine of 8-week-old male Sprague-Dawley rats (n = 4 each) and evaluated bone formation by computed tomography (CT) and pathology. Next, we administered V-FD-iMPs or saline along with artificial bone to the lumber spines of 5-week-old male New Zealand White rabbits (n = 4 each) and evaluated the bone formation by CT and pathology. Rats (n = 10) and rabbits (n = 6) that received artificial bone and V-FD-iMPs in the lumbar spine were also observed for 6 months for adverse events, including infection, tumor formation, and death.Both V-FD-iMPs and S-FD-iMPs significantly enhanced osteogenesis in the lumber spines of rats in comparison with the controls 8 weeks postoperatively, with no significant differences between them. Furthermore, V-FD-iMPs vigorously promoted osteogenesis in the lumber spines of rabbits 8 weeks postoperatively. In rats and rabbits, V-FD-iMPs showed no adverse effects, including infection, tumor formation, and death, over 6 months.These results suggest that V-FD-iMPs promote safe osteogenesis.© 2024 Japanese Society of Regenerative Medicine. Published by Elsevier B.V.