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Abstract：
BACKGROUND: There is no clear evidence on the comparative effectiveness of bone-marrow mononuclear cell (BMMNC) vs. mesenchymal stromal cell (MSC) stem cell therapy in patients with chronic heart failure (HF).
METHODS: Using a systematic approach, eligible randomized controlled trials (RCTs) of stem cell therapy (BMMNCs or MSCs) in patients with HF were retrieved to perform a meta-analysis on clinical outcomes (major adverse cardiovascular events (MACE), hospitalization for HF, and mortality) and echocardiographic indices (including left ventricular ejection fraction (LVEF)) were performed using the random-effects model. A risk ratio (RR) or mean difference (MD) with corresponding 95% confidence interval (CI) were pooled based on the type of the outcome and subgroup analysis was performed to evaluate the potential differences between the types of cells.
RESULTS: The analysis included a total of 36 RCTs (1549 HF patients receiving stem cells and 1252 patients in the control group). Transplantation of both types of cells in patients with HF resulted in a significant improvement in LVEF (BMMNCs: MD (95% CI) = 3.05 (1.11; 4.99) and MSCs: MD (95% CI) = 2.82 (1.19; 4.45), between-subgroup p = 0.86). Stem cell therapy did not lead to a significant change in the risk of MACE (MD (95% CI) = 0.83 (0.67; 1.06), BMMNCs: RR (95% CI) = 0.59 (0.31; 1.13) and MSCs: RR (95% CI) = 0.91 (0.70; 1.19), between-subgroup p = 0.12). There was a marginally decreased risk of all-cause death (MD (95% CI) = 0.82 (0.68; 0.99)) and rehospitalization (MD (95% CI) = 0.77 (0.61; 0.98)) with no difference among the cell types (p > 0.05).
CONCLUSIONS: Both types of stem cells are effective in improving LVEF in patients with heart failure without any noticeable difference between the cells. Transplantation of the stem cells could not decrease the risk of major adverse cardiovascular events compared with controls. Future trials should primarily focus on the impact of stem cell transplantation on clinical outcomes of HF patients to verify or refute the findings of this study.
METHODS: Using a systematic approach, eligible randomized controlled trials (RCTs) of stem cell therapy (BMMNCs or MSCs) in patients with HF were retrieved to perform a meta-analysis on clinical outcomes (major adverse cardiovascular events (MACE), hospitalization for HF, and mortality) and echocardiographic indices (including left ventricular ejection fraction (LVEF)) were performed using the random-effects model. A risk ratio (RR) or mean difference (MD) with corresponding 95% confidence interval (CI) were pooled based on the type of the outcome and subgroup analysis was performed to evaluate the potential differences between the types of cells.
RESULTS: The analysis included a total of 36 RCTs (1549 HF patients receiving stem cells and 1252 patients in the control group). Transplantation of both types of cells in patients with HF resulted in a significant improvement in LVEF (BMMNCs: MD (95% CI) = 3.05 (1.11; 4.99) and MSCs: MD (95% CI) = 2.82 (1.19; 4.45), between-subgroup p = 0.86). Stem cell therapy did not lead to a significant change in the risk of MACE (MD (95% CI) = 0.83 (0.67; 1.06), BMMNCs: RR (95% CI) = 0.59 (0.31; 1.13) and MSCs: RR (95% CI) = 0.91 (0.70; 1.19), between-subgroup p = 0.12). There was a marginally decreased risk of all-cause death (MD (95% CI) = 0.82 (0.68; 0.99)) and rehospitalization (MD (95% CI) = 0.77 (0.61; 0.98)) with no difference among the cell types (p > 0.05).
CONCLUSIONS: Both types of stem cells are effective in improving LVEF in patients with heart failure without any noticeable difference between the cells. Transplantation of the stem cells could not decrease the risk of major adverse cardiovascular events compared with controls. Future trials should primarily focus on the impact of stem cell transplantation on clinical outcomes of HF patients to verify or refute the findings of this study.
摘要：
背景：没有明确的证据表明骨髓单核细胞（BMMNC）与间充质基质细胞（MSC）干细胞治疗慢性心力衰竭（HF）患者。
方法：使用系统的方法，对HF患者进行干细胞治疗（BMMNCs或MSCs）的合格随机对照试验（RCTs），以对临床结局进行荟萃分析（主要不良心血管事件（MACE），HF住院治疗，和死亡率）和超声心动图指标（包括左心室射血分数（LVEF））使用随机效应模型进行。根据结果的类型合并风险比（RR）或平均差（MD）以及相应的95％置信区间（CI），并进行亚组分析以评估细胞类型之间的潜在差异。
结果：分析共包括36个RCTs（1549例接受干细胞的HF患者和1252例对照组）。两种类型的细胞在HF患者中的移植导致LVEF的显着改善（BMMNC：MD（95％CI）=3.05（1.11;4.99）和MSCs：MD（95％CI）=2.82（1.19;4.45），亚组之间p=0.86)。干细胞治疗并未导致MACE风险的显著变化(MD(95%CI)=0.83(0.67;1.06),BMMNC：RR(95%CI)=0.59(0.31;1.13)，MSC：RR(95%CI)=0.91(0.70;1.19)，亚组之间p=0.12)。全因死亡（MD（95％CI）=0.82（0.68；0.99））和再住院（MD（95％CI）=0.77（0.61；0.98））的风险略有降低，细胞类型之间没有差异（p>0.05）。
结论：两种类型的干细胞均可有效改善心力衰竭患者的LVEF，细胞之间没有任何明显差异。与对照组相比，干细胞移植不能降低主要不良心血管事件的风险。未来的试验应主要关注干细胞移植对HF患者临床结局的影响，以验证或反驳本研究的发现。
方法：使用系统的方法，对HF患者进行干细胞治疗（BMMNCs或MSCs）的合格随机对照试验（RCTs），以对临床结局进行荟萃分析（主要不良心血管事件（MACE），HF住院治疗，和死亡率）和超声心动图指标（包括左心室射血分数（LVEF））使用随机效应模型进行。根据结果的类型合并风险比（RR）或平均差（MD）以及相应的95％置信区间（CI），并进行亚组分析以评估细胞类型之间的潜在差异。
结果：分析共包括36个RCTs（1549例接受干细胞的HF患者和1252例对照组）。两种类型的细胞在HF患者中的移植导致LVEF的显着改善（BMMNC：MD（95％CI）=3.05（1.11;4.99）和MSCs：MD（95％CI）=2.82（1.19;4.45），亚组之间p=0.86)。干细胞治疗并未导致MACE风险的显著变化(MD(95%CI)=0.83(0.67;1.06),BMMNC：RR(95%CI)=0.59(0.31;1.13)，MSC：RR(95%CI)=0.91(0.70;1.19)，亚组之间p=0.12)。全因死亡（MD（95％CI）=0.82（0.68；0.99））和再住院（MD（95％CI）=0.77（0.61；0.98））的风险略有降低，细胞类型之间没有差异（p>0.05）。
结论：两种类型的干细胞均可有效改善心力衰竭患者的LVEF，细胞之间没有任何明显差异。与对照组相比，干细胞移植不能降低主要不良心血管事件的风险。未来的试验应主要关注干细胞移植对HF患者临床结局的影响，以验证或反驳本研究的发现。
