临床规模生产的人类诱导多能干细胞衍生巨核细胞和血小板的成骨效应和安全性

IF 3.4 3区 环境科学与生态学 Q3 CELL & TISSUE ENGINEERING Regenerative Therapy Pub Date : 2024-06-01 DOI:10.1016/j.reth.2024.09.012
Takahito Arai , Yasuhiro Shiga , Michiaki Mukai , Naoya Takayama , Susumu Tashiro , Ikuko Tajiri , Kentaro Kosaka , Masashi Sato , Sou Nakamura , Haruki Okamoto , Seiji Kimura , Kazuhide Inage , Miyako Suzuki-Narita , Yawara Eguchi , Sumihisa Orita , Koji Eto , Seiji Ohtori
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引用次数: 0

摘要

导言:通过离心外周血获得的富血小板血浆因含有丰富的生长因子而可促进成骨,但也有缺点,包括生长因子流失快和效果因供体因素而不一致。为了克服这些问题,我们在世界上首次使用冷冻干燥的人类诱导多能干细胞衍生巨核细胞和血小板(S-FD-iMPs),并发现它们具有促进成骨的作用。由于研究发现湍流能激活血小板的生物生成,而iPS细胞衍生的血小板目前已能通过一种名为VerMES的设备在临床上大规模生产,因此本研究对临床规模的FD-iMP(V-FD-iMPs)的成骨促进作用和安全性进行了研究,以便将来在人类临床上应用。方法我们给8周大的雄性Sprague-Dawley大鼠(每只4只)的腰椎注射S-FD-iMPs、V-FD-iMPs或生理盐水以及人工骨,并通过计算机断层扫描(CT)和病理学评估骨形成情况。接着,我们给 5 周大的雄性新西兰白兔(每只 4 只)的腰椎注射 V-FD-iMPs 或生理盐水以及人工骨,并通过 CT 和病理学评估骨形成情况。结果与对照组相比,V-FD-iMPs 和 S-FD-iMPs 在术后 8 周均能显著增强大鼠腰椎的骨生成,两者之间无显著差异。此外,V-FD-iMPs 能有力地促进家兔术后 8 周的脊柱骨生成。结论:这些结果表明,V-FD-iMPs 能安全地促进骨生成。
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Osteogenic effects and safety of human induced pluripotent stem cell-derived megakaryocytes and platelets produced on a clinical scale

Introduction

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.

Method

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.

Results

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.

Conclusion

These results suggest that V-FD-iMPs promote safe osteogenesis.
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来源期刊
Regenerative Therapy
Regenerative Therapy Engineering-Biomedical Engineering
CiteScore
6.00
自引率
2.30%
发文量
106
审稿时长
49 days
期刊介绍: Regenerative Therapy is the official peer-reviewed online journal of the Japanese Society for Regenerative Medicine. Regenerative Therapy is a multidisciplinary journal that publishes original articles and reviews of basic research, clinical translation, industrial development, and regulatory issues focusing on stem cell biology, tissue engineering, and regenerative medicine.
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