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Cell Therapy for Treatment of Intervertebral Disc Degeneration: ASystematic Review

机译:细胞疗法治疗椎间盘退变:系统评价

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Study Design: Systematic review. Objective: To review, critically appraise, and synthesize evidence on use of cell therapy for intervertebral disc repair. Methods: A systematic search of PubMed/MEDLINE was conducted for literature published through October 31, 2018 and EMBASE and ClinicalTrials.gov databases through April 13, 2018 comparing allogenic or autologous cell therapy for intervertebral disc (IVD) repair in the lumbar or cervical spine. In the absence of comparative studies, case series of ≥10 patients were considered. Results: From 1039 potentially relevant citations, 8 studies across 10 publications on IVD cell therapies in the lumbar spine met the inclusion criteria. All studies were small and primarily case series. For allogenic cell sources, no difference in function or pain between mesenchymal cell treatment and sham were reported in 1 small randomized controlled trial; 1 small case series reported improved function and pain relative to baseline but it was unclear if the change was clinically significant. Similarly for autologous cell sources, limited data across case series suggest pain and function may be improved relative to baseline; whether the changes were clinically significant was not clear. Safety data was sparse and poorly reported. The need for subsequent surgery was reported in 3 case-series studies ranging from 6% to 80%. Conclusions: The overall strength of evidence for efficacy and safety of cell therapy for lumbar IVD repair was very low primarily due to substantial risk of bias, small sample sizes and lack of a comparator intervention. Methodologically sound studies comparing cell therapies to other treatments are needed.
机译:研究设计:系统评价。目的:审查,批判评估和综合使用细胞疗法修复椎间盘的证据。方法:对PubMed / MEDLINE进行了系统的搜索,以检索截至2018年10月31日出版的文献以及截至2018年4月13日的EMBASE和ClinicalTrials.gov数据库,比较同种异体或自体细胞疗法对腰椎或颈椎椎间盘(IVD)的修复作用。在没有比较研究的情况下,考虑了≥10例患者的病例系列。结果:从1039篇可能相关的引文中,涉及10篇有关腰椎IVD细胞疗法的出版物的8项研究符合纳入标准。所有研究均为小样本,主要是病例系列。对于同种异体细胞来源,在一项小型随机对照试验中,间充质细胞治疗与假手术之间在功能或疼痛方面无差异。 1个小病例系列报告了相对于基线改善的功能和疼痛,但尚不清楚该改变是否具有临床意义。同样,对于自体细胞来源,整个病例系列的有限数据表明疼痛和功能可能相对于基线有所改善。这些变化是否具有临床意义尚不清楚。安全数据稀少,报告不力。 3个病例系列研究报告了对后续手术的需求,范围从6%到80%。结论:腰椎IVD修复的细胞疗法的有效性和安全性的综合证据非常低,这主要是由于存在偏倚的巨大风险,小样本量以及缺乏比较者干预。需要进行方法学上合理的研究,将细胞疗法与其他疗法进行比较。

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