An exploratory clinical trial for concentrated autologous bone marrow aspirate transplantation in the treatment of osteonecrosis of the femoral head

被引:1
作者
Sugaya, Hisashi [1 ,2 ]
Yoshioka, Tomokazu [2 ,3 ]
Tomaru, Yohei [2 ]
Kumagai, Hiroshi [2 ]
Yamazaki, Masashi [2 ]
Mishima, Hajime [2 ]
机构
[1] Tsukuba Univ Technol, Fac Hlth Sci, Dept Hlth, Tsukuba, Ibaraki, Japan
[2] Univ Tsukuba, Fac Med, Dept Orthopaed Surg, Tsukuba, Ibaraki, Japan
[3] Univ Tsukuba, Fac Med, Div Regenerat Med Musculoskeletal Syst, Tsukuba, Ibaraki, Japan
关键词
Osteonecrosis of the femoral head; Bone marrow aspirate concentrate; Regenerative medicine; Low-intensity pulsed ultrasound; INTENSITY PULSED ULTRASOUND; FOLLOW-UP; STEM; STIMULATION;
D O I
10.1007/s00590-022-03201-6
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
Purpose This study evaluated the efficacy and safety of a novel treatment for osteonecrosis, in which concentrated autologous bone marrow aspirate transplantation (CABMAT) is followed by low-intensity pulsed ultrasound (LIPUS) stimulation for 3 months. The study was designed as a prospective, uncontrolled, open-label phase II clinical study. Methods This study included 16 cases of osteonecrosis of the femoral head (ONFH), including 26 hips. Patients were transplanted with concentrated bone marrow and periodically evaluated for infection and neoplasm development. Moreover, clinical and radiological examinations were conducted to confirm the treatment efficacy. Results No infections were observed during the course of this study nor tumours developed at the treatment site 24 months after transplantation. At a mean 48 (30-56) months post-transplantation, the onset or progression of collapse was noted in four hips, of which one hip underwent total hip arthroplasty. Conclusion Treatment with CABMAT combined with 3-month LIPUS stimulation was safe, and further randomised clinical studies are needed to determine the efficacy and feasibility of this treatment.
引用
收藏
页码:441 / 447
页数:7
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