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Cell therapy for the treatment of tendinopathy - A systematic review on the pre-clinical and clinical evidence

机译:细胞疗法治疗肌腱病-临床前和临床证据的系统评价

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Objectives: This review aimed to summarize the current evidence on the safety/efficacy of cell therapy for the treatment of tendinopathy. Methods: A systematic literature search was conducted using various databases with relevant keywords. Both original animal and human controlled studies, covering any cell type for the treatment of naturally occurring, overuse or collagenase-induced tendinopathy, and with full text available, were included. The quality of all included studies was assessed. Relevant data on study design, safety and efficacy outcomes were extracted. Results: Eleven original studies were selected, of which nine were pre-clinical studies using the collagenase-induced tendon injury model and two were clinical studies. Types of cells, scaffolds, dosages and treatment regimens used varied. All the studies performed cell injection once. A critical appraisal of the included studies showed sub-optimal blinding. Cell therapy was generally reported to be safe, except minor complications, in the short term. Cell therapy was reported to improve tendon architecture in histology but equivocal finding was observed in sonographic/MRI examination, functional and biomechanical performance. Conclusions: The current evidence was inadequate to make a conclusion whether cell therapy was safe and effective. Further study with adequate sample size and follow-up time, appropriate controls and optimal blinding is required. Confirmation of finding, using different tendinopathy animal models, by systematic investigation of the effects of cell sources, dosages and regimens on the outcomes, and by the inclusion of tendon pain assessment in both animals and human, is recommended. Research on the mechanisms of how cell worked in tendon repair is essential.
机译:目的:本综述旨在总结有关细胞疗法治疗肌腱病的安全性/有效性的最新证据。方法:使用具有相关关键词的各种数据库进行系统的文献检索。原始动物和人类对照研究均涵盖了用于治疗自然发生,过度使用或胶原酶诱导的肌腱病的任何细胞类型,并提供了全文。评估所有纳入研究的质量。提取了有关研究设计,安全性和疗效结果的相关数据。结果:选择了11篇原始研究,其中9篇是使用胶原酶诱导的肌腱损伤模型进行的临床前研究,其中2篇是临床研究。使用的细胞类型,支架,剂量和治疗方案各不相同。所有研究一次进行细胞注射。对纳入研究的严格评估显示,亚盲是次优的。在短期内,一般认为细胞疗法是安全的,除了较小的并发症。据报道,细胞疗法可改善组织学中的肌腱结构,但在超声/ MRI检查,功能和生物力学性能中发现模棱两可的发现。结论:目前的证据不足以得出细胞疗法是否安全有效的结论。需要有足够的样本量和随访时间,适当的对照以及最佳的盲法进行进一步研究。建议通过使用不同的肌腱病动物模型,系统地研究细胞来源,剂量和治疗方案对预后的影响以及通过在动物和人体内进行肌腱疼痛评估来确认发现。研究细胞如何在肌腱修复中发挥作用的机制至关重要。

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