Miplant Stems Clinic, Seoul, Korea.
Pain Physician. 2012 Jan-Feb;15(1):75-85.
Osteonecrosis, also known as avascular necrosis, of the femoral head is a debilitating disorder that commonly affects 30- to 50-year-old individuals. Currently, definitive treatment is limited to total hip replacement. However, recent studies have demonstrated bone regeneration in the femoral head after the infusion of bone marrow-derived mesenchymal stem cells. In addition, local injection of adipose tissue-derived stem cells has been shown to regenerate medullary bone-like tissue 3 months after treatment. However, there have been no long-term follow-up studies on humans treated with adipose tissue-derived stem cells for osteonecrosis.
To determine if treatment with adipose tissue-derived stem cells and platelet-rich plasma leads to the regeneration of medullary bone-like tissue and long-term reduction of hip pain in patients with femoral head osteonecrosis.
This report of two clinical cases was in compliance with the Declaration of Helsinki. Also, the Korean Food and Drug Administration has allowed the use of adipose tissue-derived stem cells (ADSCs) in medical treatments since 2009. To obtain ADSCs, lipoaspirates were obtained from lower abdominal subcutaneous adipose tissue. The stromal vascular fraction was separated from the lipoaspirates by centrifugation after treatment with collagenase. The stem-cell-containing stromal vascular fraction was mixed with calcium chloride-activated platelet rich plasma and hyaluronic acid, and this mixture was then injected into the diseased hip. The affected hip was reinjected with calcium chloride-activated platelet rich plasma weekly for 4 weeks. Patients were subjected to pre- and post-treatment magnetic resonance imaging (MRI) scans.
Two patients (34- and 39-year-old men) with femoral head osteonecrosis and severe hip pain were treated with adipose-derived stem cells. The MRI scans of the affected hip in both patients showed segmental areas of low signal intensity (T1 axial views) in the subchondral bones with a "double line sign" consistent with osteonecrosis. The visual analog scale score, physical therapy testing, and Harris Hip score of both patients improved after stem cell treatment. Both patients also demonstrated post-procedure improvement in their MRI scans, evidenced by positive T1 signal changes consistent with medullary bone regeneration. Further, the long-term reduction in hip pain was correlated with the MRI findings indicative of bone regeneration.
A biopsy of the regenerated tissue was not conducted in either patient. Thus, the true nature of the treatment-induced changes is unknown. Further, the MRI results may contain artifacts due to the difficulty in capturing the exact treatment location. It can only be speculated that there was neovascularization to support the newly regenerated medullary bone-like tissue.
These 2 cases demonstrate the presence of sustained, regenerated medullary bone-like tissue in 2 severely necrotic femoral heads and suggest that this rather simple, minimally invasive percutaneous procedure may hold great promise as a therapy for patients with femoral head osteonecrosis.
股骨头坏死，又称无菌性坏死，是一种常见于 30 至 50 岁人群的致残性疾病。目前，明确的治疗方法仅限于全髋关节置换术。然而，最近的研究表明，骨髓间充质干细胞输注后股骨头内有骨再生。此外，脂肪组织源性干细胞的局部注射治疗后 3 个月可再生骨髓样组织。然而，目前还没有对接受脂肪组织源性干细胞治疗的股骨头坏死患者进行长期随访的研究。
确定脂肪组织源性干细胞和富含血小板的血浆治疗是否会导致股骨头坏死患者骨髓样组织再生和长期髋关节疼痛减轻。
本报告中的两例临床病例均符合赫尔辛基宣言。此外，韩国食品药品管理局自 2009 年以来允许将脂肪组织源性干细胞（ADSCs）用于医疗。为了获得 ADSCs，从下腹部皮下脂肪组织中提取脂肪抽吸物。用胶原酶处理后，通过离心将脂肪抽吸物中的基质血管部分与氯化钙激活的富含血小板的血浆和透明质酸分离。将含有干细胞的基质血管部分与氯化钙激活的富含血小板的血浆和透明质酸混合，然后将混合物注入患病髋关节。每周对患病髋关节进行氯化钙激活的富含血小板的血浆 4 周的再注射。患者接受治疗前后的磁共振成像（MRI）扫描。
两名（34 岁和 39 岁）男性股骨头坏死和严重髋关节疼痛患者接受了脂肪源性干细胞治疗。两名患者患病髋关节的 MRI 扫描显示，软骨下骨呈低信号强度（T1 轴位）的节段性区域，具有与骨坏死一致的“双线征”。两名患者的视觉模拟量表评分、物理治疗测试和哈里斯髋关节评分在干细胞治疗后均有所改善。两名患者的 MRI 扫描也显示术后改善，表现为与骨髓再生一致的 T1 信号变化阳性。此外，髋关节疼痛的长期减轻与 MRI 显示的骨再生结果相关。
两名患者均未进行再生组织的活检。因此，治疗引起的变化的真实性质尚不清楚。此外，MRI 结果可能由于难以捕捉确切的治疗部位而存在伪影。只能推测有新生血管化来支持新再生的骨髓样组织。
这两个病例证明了两个严重坏死的股骨头中有持续的再生骨髓样组织存在，并表明这种相当简单、微创的经皮手术可能为股骨头坏死患者的治疗带来很大的希望。
