Background and Objective: Stem cell therapy has emerged as a potential therapy for the treatment of stroke. We performed a systematic review and meta-analysis of published randomized controlled studies using various types of stem cell therapies in patients with ischemic stroke (IS). Method: Literature search was carried out using PubMed, Google Scholar, Cochrane library, and clinicaltrial.gov to identify studies on stem cell therapy in IS from its inception till January 2020. Data were extracted independently by two reviewers. STATA version 13 was used for carrying out meta- analysis. We included only randomized controlled trials (RCTs) if any of the stem cell therapy was used to treat patients with IS in any phase after the index stroke. Results: We included a total of eight randomized controlled studies involving 459 subjects (217 intervention and 242 controls) in the meta-analysis. We did not observe statistically significant reduction in mean NIHSS score in the intervention group (SMD - 0.34, 95% CI - 0.76 to 0.08) in patients with acute or sub-acute stroke. However, a statistically significant reduction (SMD - 1.57, 95% CI -2.22 to -0.92) was observed in patients with chronic ischemic stroke. Statistically non-significant reduction in mean mRS in the intervention group (SMD 0.04, 95% CI -0.20 to 0.28) in patients with acute or sub-acute ischemic stroke was observed, however a statistically significant reduction (SMD - 1.07, 95% CI - 1.94 to -0.19) was noted in patients with chronic stroke. We did not observe statistically significant reduction in mean Barthel index score (SMD 0.24, 95%CI -1.69 to 2.17) in chronic stroke. Statistically non-significant lower mortality rate was observed in intervention group compared to controls (Risk Ratio 0.84, 95% CI 0.43 to 1.66) among acute or sub-acute, as well as in the chronic stroke group (Risk Ratio 0.47, 95% CI 0.20 to 1.09). Conclusion: Our meta-analysis provides no clinically important evidence for efficacy of stem cells in reducing neurological deficit compared to control group. Well-designed large randomized controlled trials are required to provide more information on the efficacy of stem cell therapy in patients with IS.


中文翻译：

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干细胞治疗缺血性卒中：随机对照试验的系统评价和荟萃分析


背景与目的：干细胞疗法已成为治疗中风的潜在疗法。我们对已发表的使用各种干细胞疗法治疗缺血性卒中 (IS) 患者的随机对照研究进行了系统回顾和荟萃分析。方法：使用 PubMed、Google Scholar、Cochrane 图书馆和clinicaltrial.gov 进行文献检索，以确定从IS 开始到2020 年1 月的干细胞治疗研究。数据由两名审稿人独立提取。STATA 第 13 版用于进行荟萃分析。如果任何干细胞疗法用于治疗中风后任何阶段的 IS 患者，我们仅纳入随机对照试验 (RCT)。结果：我们在荟萃分析中纳入了总共 8 项随机对照研究，涉及 459 名受试者（217 名干预和 242 名对照）。我们没有观察到干预组急性或亚急性卒中患者的平均 NIHSS 评分有统计学意义的降低（SMD - 0.34, 95% CI - 0.76 至 0.08）。然而，在慢性缺血性卒中患者中观察到统计学显着降低（SMD - 1.57, 95% CI -2.22 至 -0.92）。在急性或亚急性缺血性卒中患者中观察到干预组的平均 mRS 降低（SMD 0.04, 95% CI -0.20 至 0.28）无统计学意义，但有统计学意义的降低（SMD - 1.07, 95% CI - 1.94 至 -0.19）在慢性中风患者中被注意到。我们没有观察到平均 Barthel 指数评分（SMD 0.24，95%CI -1.69 至 2.17）在慢性中风。在急性或亚急性以及慢性卒中组（风险比 0.47, 95% CI 0.20 至 1.09）。结论：与对照组相比，我们的荟萃分析没有为干细胞在减少神经功能缺损方面的功效提供临床上重要的证据。需要精心设计的大型随机对照试验来提供更多关于干细胞治疗对 IS 患者疗效的信息。