Shimomura Kazunori, Ando Wataru, Hart David A, Yonetani Yasukazu, Horibe Shuji, Nakamura Norimasa
Department of Rehabilitation, Kansai University of Welfare Sciences, Osaka, Japan.
Department of Orthopaedic Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Orthop J Sports Med. 2023 Aug 8;11(8):23259671231189474. doi: 10.1177/23259671231189474. eCollection 2023 Aug.
In an earlier study, a scaffold-free tissue-engineered construct (TEC) derived from autologous synovial membrane mesenchymal stromal cells (MSCs) was developed and demonstrated to be safe and effective for cartilage repair at 2 years postoperatively.
To investigate clinical outcomes and magnetic resonance imaging (MRI) findings at 5 years after implantation.
Case series; Level of evidence, 4.
This was an observational first-in-human study limited to 5 patients (age, 28-46 years) with symptomatic knee chondral lesions (size, 1.5-3.0 cm) on the medial femoral condyle, lateral femoral condyle, or femoral groove. Synovial MSCs were isolated from arthroscopic biopsy specimens and cultured to develop a TEC that matched the lesion size. The TECs were then implanted into chondral defects without fixation and assessed at up to 5 years postoperatively. The patients were clinically evaluated using the visual analog scale for pain, Lysholm score, Tegner score, and Knee injury and Osteoarthritis Outcome Score. An MRI scan evaluation was also performed for morphologic and compositional quality of the repair tissue at both 2 and 5 years of follow-up.
All clinical scores were significantly improved from the preoperative evaluation to the 2- and 5-year follow-ups and the results were stable over time. The MRI scan evaluation showed cartilage defects filled with newly generated tissues with good tissue integration to adjacent host cartilage over time. The cartilage thickness and surface smoothness of the repair cartilage were maintained up to 5 years postoperatively. The MOCART (magnetic resonance observation of cartilage repair tissue) 2.0 Knee Scores remained high at 5 years, although the total points decreased slightly.
The results highlight the efficacy and feasibility of autologous scaffold-free TEC derived from synovial MSCs for regenerative cartilage repair via a sutureless and simple implantation procedure, showing good clinical outcomes and MRI findings with stable results at midterm follow-up. Further follow-up will be needed to assess the long-term quality of the repair tissue.
在一项早期研究中,开发了一种源自自体滑膜间充质基质细胞(MSC)的无支架组织工程构建体(TEC),并证明其在术后2年对软骨修复是安全有效的。
研究植入后5年的临床结果和磁共振成像(MRI)表现。
病例系列;证据等级,4级。
这是一项观察性的首例人体研究,限于5例(年龄28 - 46岁)有症状的膝关节软骨损伤患者,损伤位于股骨内侧髁、外侧髁或股骨沟,损伤大小为1.5 - 3.0 cm。从关节镜活检标本中分离滑膜间充质干细胞并进行培养,以构建与损伤大小匹配的TEC。然后将TEC植入软骨缺损处,不进行固定,并在术后长达5年的时间里进行评估。使用视觉模拟疼痛评分、Lysholm评分、Tegner评分以及膝关节损伤和骨关节炎转归评分对患者进行临床评估。在随访的2年和5年时,还进行了MRI扫描评估,以观察修复组织的形态和成分质量。
从术前评估到2年和5年随访,所有临床评分均显著改善,且结果随时间保持稳定。MRI扫描评估显示,随着时间推移,软骨缺损处填充有新生成的组织,且与相邻宿主软骨有良好的组织整合。修复软骨的厚度和表面光滑度在术后5年内得以维持。尽管总分略有下降,但MOCART(软骨修复组织的磁共振观察)2.0膝关节评分在5年时仍保持较高水平。
结果突出了源自滑膜间充质干细胞的自体无支架TEC通过无缝合且简单的植入程序进行再生软骨修复的有效性和可行性,在中期随访中显示出良好的临床结果和MRI表现,且结果稳定。需要进一步随访以评估修复组织长期质量。