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Cell therapy for nonischemic dilated cardiomyopathy: A systematic review and meta-analysis of randomized controlled trials
STEM CELLS Translational Medicine ( IF 5.4 ) Pub Date : 2021-08-04 , DOI: 10.1002/sctm.21-0094 Avnish Tripathi 1 , Mohammad Saud Khan 1, 2 , Abdur Rahman Khan 3 , Vida M Vaughn 3 , Roberto Bolli 4
STEM CELLS Translational Medicine ( IF 5.4 ) Pub Date : 2021-08-04 , DOI: 10.1002/sctm.21-0094 Avnish Tripathi 1 , Mohammad Saud Khan 1, 2 , Abdur Rahman Khan 3 , Vida M Vaughn 3 , Roberto Bolli 4
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Cell therapy involves transplantation of human cells to promote repair of diseased or injured tissues and/or cells. Only a limited number of mostly small-scale trials have studied cell therapy in nonischemic cardiomyopathy (NICM). We performed a meta-analysis of randomized clinical trials (RCTs) to assess the safety and efficacy of cell therapy in NICM. Electronic databases were searched for relevant RCTs from inception until August 2020. Outcomes assessed were left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter or volume (LVEDD), quality of life (QoL) indices, and major adverse cardiac events (MACEs). Weighted mean differences (MDs) and standardized mean differences (SMDs) were calculated using random-effects methods. Eleven RCTs with 574 participants were included in the analysis. There was a significant increase in mean LVEF (MD, 4.17%; 95% confidence interval [CI] = 1.66-6.69) and modest decrease in LVEDD (SMD, −0.50; 95% CI = −0.95 to −0.06) in patients treated with cell therapy compared with controls. Cell therapy was also associated with improvement in functional capacity, as assessed by the 6-minute walking distance (MD, 72.49 m; 95% CI = 3.44-141.53). No significant differences were seen in MACEs and QoL indices between treated and control groups. This meta-analysis suggests that cell therapy may improve LV systolic function and may be associated with improvement in LVEDD and functional capacity compared with maximal medical therapy. Cell therapy was safe, with no significant difference in MACEs between treatment and control groups. However, given the limitations of current studies, larger well-designed RCTs are needed to evaluate the efficacy of cell therapy in patients with NICM.
中文翻译：
非缺血性扩张型心肌病的细胞疗法：随机对照试验的系统评价和荟萃分析
细胞疗法涉及移植人体细胞以促进患病或受伤的组织和/或细胞的修复。只有数量有限且大多是小规模的试验研究了非缺血性心肌病（NICM）的细胞疗法。我们对随机临床试验 (RCT) 进行了荟萃分析，以评估细胞疗法在 NICM 中的安全性和有效性。在电子数据库中搜索了从开始到 2020 年 8 月的相关随机对照试验。评估的结果包括左心室射血分数 (LVEF)、左心室舒张末期直径或容积 (LVEDD)、生活质量 (QoL) 指数和主要不良心脏事件。 MACE）。使用随机效应方法计算加权平均差（MD）和标准化平均差（SMD）。分析中纳入了 11 项随机对照试验，涉及 574 名参与者。接受治疗的患者平均 LVEF（MD，4.17%；95% 置信区间 [CI] = 1.66-6.69）显着增加，LVEDD 适度下降（SMD，-0.50；95% CI = -0.95 至 -0.06）与对照组相比，细胞疗法。通过 6 分钟步行距离评估，细胞疗法还与功能能力的改善相关（MD，72.49 m；95% CI = 3.44-141.53）。治疗组和对照组之间的 MACE 和 QoL 指数没有显着差异。这项荟萃分析表明，与最大程度的药物治疗相比，细胞疗法可以改善左心室收缩功能，并且可能与左心室舒张末期（LVEDD）和功能能力的改善有关。细胞疗法是安全的，治疗组和对照组之间的 MACE 没有显着差异。然而，鉴于当前研究的局限性，需要更大规模、精心设计的随机对照试验来评估细胞疗法对 NICM 患者的疗效。
更新日期：2021-09-23
中文翻译：
非缺血性扩张型心肌病的细胞疗法：随机对照试验的系统评价和荟萃分析
细胞疗法涉及移植人体细胞以促进患病或受伤的组织和/或细胞的修复。只有数量有限且大多是小规模的试验研究了非缺血性心肌病（NICM）的细胞疗法。我们对随机临床试验 (RCT) 进行了荟萃分析，以评估细胞疗法在 NICM 中的安全性和有效性。在电子数据库中搜索了从开始到 2020 年 8 月的相关随机对照试验。评估的结果包括左心室射血分数 (LVEF)、左心室舒张末期直径或容积 (LVEDD)、生活质量 (QoL) 指数和主要不良心脏事件。 MACE）。使用随机效应方法计算加权平均差（MD）和标准化平均差（SMD）。分析中纳入了 11 项随机对照试验，涉及 574 名参与者。接受治疗的患者平均 LVEF（MD，4.17%；95% 置信区间 [CI] = 1.66-6.69）显着增加，LVEDD 适度下降（SMD，-0.50；95% CI = -0.95 至 -0.06）与对照组相比，细胞疗法。通过 6 分钟步行距离评估，细胞疗法还与功能能力的改善相关（MD，72.49 m；95% CI = 3.44-141.53）。治疗组和对照组之间的 MACE 和 QoL 指数没有显着差异。这项荟萃分析表明，与最大程度的药物治疗相比，细胞疗法可以改善左心室收缩功能，并且可能与左心室舒张末期（LVEDD）和功能能力的改善有关。细胞疗法是安全的，治疗组和对照组之间的 MACE 没有显着差异。然而，鉴于当前研究的局限性，需要更大规模、精心设计的随机对照试验来评估细胞疗法对 NICM 患者的疗效。
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