干细胞治疗椎间盘源性疼痛的安全性和有效性——对人类研究的系统回顾

Christine L. Hunt DO, MS , Stephanie Shen MD , Ahmad Nassr MD , Andre J. van Wijnen PhD , A. Noelle Larson MD , Jason S. Eldrige MD , William D. Mauck MD , Mathew J. Pingree MD , Patricia J. Erwin MLS , Mohamad Bydon MD , Wenchun Qu MD, MS, PhD
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引用次数: 3

摘要

本研究是对干细胞治疗椎间盘源性疼痛的人类临床研究的系统综述。总结间充质干细胞(MSC)治疗椎间盘源性疼痛的临床试验和可行性研究。从Ovid数据库和Clinicaltrials.gov的成立到2016年7月进行了搜索。我们纳入了人类临床试验和病例报告,评估了椎间盘源性背痛患者注射间充质干细胞的治疗。已发表的研究中关注的结果包括疼痛评分、Oswestry残疾指数和指示髓核含水量的t2加权磁共振成像信号强度。使用选定的搜索词在Ovid数据库中进行初始搜索,确定了408个结果,其中11个根据选择标准被纳入本综述。这包括6项已完成的研究和5项正在进行的临床试验,其中4项在检索时确认有效。在已完成的6项涉及椎间盘内干细胞注射的研究中,报告了疼痛评分、Oswestry残疾指数和髓核t2加权磁共振成像信号强度的改善。目前正在进行的临床试验侧重于建立注射间充质干细胞治疗椎间盘源性疼痛的安全性、耐受性和有效性。尽管疼痛和功能益处已被报道与干细胞治疗相关,但需要更长期的安全性研究和更多的随机对照试验来检验干细胞治疗椎间盘源性疼痛的安全性和有效性。
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Current understanding of safety and efficacy of stem cell therapy for discogenic pain—A systematic review of human studies

This study is a systematic review of human clinical studies of stem cell therapy for discogenic pain. To summarize the current human trials and feasibility studies involving mesenchymal stem cell (MSC) therapy for treatment of discogenic pain. A search of Ovid databases and Clinicaltrials.gov was conducted from inception through July 2016. We included human clinical trials and case reports that evaluated treatment with injected MSCs for patients with discogenic back pain. The outcomes of interest for published studies included pain score, Oswestry Disability Index, and T2-weighted magnetic resonance imaging signal intensity indicative of water content of the nucleus pulposus. The initial search in Ovid databases using the selected search terms identified 408 results, of which 11 were included in this review based on selection criteria. This includes 6 completed studies and 5 ongoing clinical trials, 4 of which were confirmed active at the time of retrieval. In the 6 completed studies involving intradiscal stem cell injections, improvement in pain score, Oswestry Disability Index, and T2-weighted magnetic resonance imaging signal intensity of nucleus pulposus were reported. Currently active clinical trials focus on establishing safety, tolerability, and efficacy with respect to injected MSCs for discogenic pain. Although pain and functional benefit have been reported in association with stem cell therapy, longer-term safety studies and more randomized controlled trials are needed to examine the safety and efficacy of stem cell therapy for discogenic pain.

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