Mirghaderi Seyed Peyman, Valizadeh Zahra, Shadman Kimia, Lafosse Thibault, Oryadi-Zanjani Leila, Yekaninejad Mir Saeed, Nabian Mohammad Hossein
Center of Orthopedic Trans-Disciplinary Applied Research (COTAR), Tehran University of Medical Sciences, Tehran, Iran.
Students' Scientific Research Center (SSRC), Tehran University of Medical Sciences, Tehran, Iran.
J Exp Orthop. 2022 Aug 30;9(1):85. doi: 10.1186/s40634-022-00520-9.
Despite substantial animal evidence, cell therapy in humans remains in its infancy. The purpose of this study was to examine the potential therapeutic effects and safety of cell therapy in the treatment of tendon disorders.
According to the PRISMA guideline, a systematic review was performed on clinical studies concerning cell therapy in tendon disorders. A comprehensive search including the 5 databases of MEDLINE, Embase, Scopus, Web of Science, and Cochrane Library until December 2021 was carried out and associated with hand searching. The quality of the eligible studies was assessed using the tools suggested by Cochrane recommendations. Qualitative synthesis was performed in 2 tables and discussed separately for rotator cuff, elbow, patella, Achilles, and gluteal tendons.
Through 6017 records, 22 studies were included in the qualitative synthesis, including 658 patients. All the studies administered autologous cells, except one that used allogenic adipose-derived mesenchymal stem cells (Allogenic AD-MSC). Almost all studies demonstrated the safety of cell injection in their follow-up period with no serious side effects or immunologic reactions, with only a few related minor adverse events in some cases. The included studies showed the effectiveness of cell injection in tendinopathies of different sites, rotator cuff, elbow, patella, Achilles, and gluteal tendons. Among the rotator cuff studies, 4 comparative studies claimed that cell therapy is a more efficient treatment with a lower retear rate and pain level compared to the control group. However, one study found no differences between the groups. No controlled study has been performed on elbow tendinopathies, but 5 case series demonstrated the effectiveness of cell injection in elbow tendon disorders. For Achilles tendinopathies, only one randomized controlled trial (RCT) found that both cell therapy and control groups showed significant pain reduction and functional improvement with no statistical differences at the 6 months follow-up, but the cell therapy group had improved faster at earlier follow-ups. Patellar tendinopathy was studied in 2 RCTs, one did not show a significant difference and the other showed superior improvement compared to controls.
Cell therapy showed promising results and the available evidence suggests that it is safe at several sites of tendon disease. Based on available evidence, cell therapy should be suggested in specific conditions at each site. To approve cell therapy for tendon diseases, randomized clinical trials are required with a large sample size and long-term follow-ups.
IV.
尽管有大量动物实验证据，但细胞治疗在人类中的应用仍处于起步阶段。本研究旨在探讨细胞治疗在肌腱疾病治疗中的潜在治疗效果和安全性。
根据PRISMA指南，对有关肌腱疾病细胞治疗的临床研究进行系统评价。进行了全面检索，包括截至2021年12月的MEDLINE、Embase、Scopus、Web of Science和Cochrane图书馆这5个数据库，并结合手工检索。使用Cochrane推荐的工具评估符合条件的研究的质量。在2个表格中进行定性综合，并分别针对肩袖、肘部、髌骨、跟腱和臀肌腱进行讨论。
通过6017条记录，22项研究被纳入定性综合分析，包括658例患者。除1项使用异体脂肪来源间充质干细胞（Allogenic AD-MSC）的研究外，所有研究均使用自体细胞。几乎所有研究在随访期间都证明了细胞注射的安全性，没有严重的副作用或免疫反应，仅在某些情况下出现了一些相关的轻微不良事件。纳入的研究显示了细胞注射在不同部位肌腱病（肩袖、肘部、髌骨、跟腱和臀肌腱）中的有效性。在肩袖研究中，4项比较研究称，与对照组相比，细胞治疗是一种更有效的治疗方法，再撕裂率和疼痛程度更低。然而，1项研究发现两组之间没有差异。尚未对肘部肌腱病进行对照研究，但5个病例系列证明了细胞注射在肘部肌腱疾病中的有效性。对于跟腱病，只有1项随机对照试验（RCT）发现，细胞治疗组和对照组在6个月随访时疼痛均显著减轻，功能均有改善，无统计学差异，但细胞治疗组在早期随访时改善更快。在2项RCT中对髌腱病进行了研究，1项未显示出显著差异，另1项显示与对照组相比改善更优。
细胞治疗显示出有前景的结果，现有证据表明其在多个肌腱疾病部位是安全的。根据现有证据，应在每个部位的特定条件下建议使用细胞治疗。为批准细胞治疗用于肌腱疾病，需要进行大样本量和长期随访的随机临床试验。
IV级。
