Homma Yasuhiro, Masubuchi Yosuke, Shirogane Yuichi, Amano Hirofumi, Muramoto Yuko, Nagao Masashi, Okuno Ryuji, Baba Tomonori, Yamaji Ken, Tamura Naoto, Kaneko Kazuo, Ishijima Muneaki
Department of Orthopaedics, Faculty of Medicine, Juntendo University, Tokyo, Japan.
Medical Technology Innovation Center, Juntendo University, Japan.
Regen Ther. 2022 Mar 18;20:18-25. doi: 10.1016/j.reth.2022.03.002. eCollection 2022 Jun.
Along with the accumulating reports of autologous concentrated bone marrow (CBM) grafting for osteonecrosis of the femoral head (ONFH), the related medical device, a "point-of-care device" has also been recently developed. However, no study has confirmed the feasibility, safety, and efficiency of CBM grafting using a specific point-of-care device.
We designed this phase I, prospective clinical study to evaluate the feasibility and safety of autologous CBM grafting processed using a point-of-care device, the BioCUE system, in patients with ONFH. The primary outcomes were the safety and adverse event (AE), the secondary outcomes included pain score; hip function score; ONFH stage using X-ray; and the volume of the osteonecrotic area on 3T MRI. Besides, safety quality tests on the final product of concentrated bone marrow were performed.
Two patients (a 34-year-old man and a 33-year-old woman; three hips) with systemic lupus erythematosus were included. The incidence of AEs was 100% such as pain or transient fever after the operation, but all AEs were nonserious. No peri-operative complications were observed. Pain and hip function score remained unchanged from the preoperative to the postoperative observational periods. Safety quality test demonstrated were all negative or under the threshold.
The feasibility and safety of grafting of concentrated autologous CBM in patients with ONFH using a point-of-care device were confirmed. A further clinical study aiming for the authorization of this procedure should be conducted in the future.
随着自体浓缩骨髓（CBM）移植治疗股骨头坏死（ONFH）的报道不断增多，一种相关的医疗设备——“床旁即时检测设备”最近也已研发出来。然而，尚无研究证实使用特定床旁即时检测设备进行CBM移植的可行性、安全性和有效性。
我们设计了这项I期前瞻性临床研究，以评估使用床旁即时检测设备BioCUE系统对ONFH患者进行自体CBM移植的可行性和安全性。主要结局为安全性和不良事件（AE），次要结局包括疼痛评分、髋关节功能评分、使用X线评估的ONFH分期以及3T MRI上骨坏死区域的体积。此外，还对浓缩骨髓的最终产品进行了安全性质量检测。
纳入了两名系统性红斑狼疮患者（一名34岁男性和一名33岁女性；共三个髋关节）。AE的发生率为100%，如术后疼痛或短暂发热，但所有AE均不严重。未观察到围手术期并发症。从术前到术后观察期，疼痛和髋关节功能评分均保持不变。安全性质量检测结果均为阴性或低于阈值。
证实了使用床旁即时检测设备对ONFH患者进行自体浓缩CBM移植的可行性和安全性。未来应开展进一步的临床研究以获得该手术的批准。
