同种异体与自体间充质干细胞治疗射血分数降低的心力衰竭患者的优劣性尚无定论：一项随机对照试验的系统评价和荟萃分析

The inconclusive superiority debate of allogeneic versus autologous MSCs in treating patients with HFrEF: a systematic review and meta-analysis of RCTs.

作者信息

Ahmed Omar T F, Ahmed Ziyad Tarek, Dairi Abdulrahman W, Zain Al-Abeden Maha Saad, Alkahlot Mohammed H, Alkahlot Rana H, Al Jowf Ghazi I, Eijssen Lars M T, Haider Khawaja Husnain

机构信息

College of Medicine, Sulaiman Alrajhi University, 52726, Al-Bukairiyah, Saudi Arabia.

Department of Public Health, College of Applied Medical Sciences, King Faisal University, 31982, Al-Ahsa, Saudi Arabia.

出版信息

Stem Cell Res Ther. 2025 Apr 12;16(1):175. doi: 10.1186/s13287-025-04209-5.

DOI:10.1186/s13287-025-04209-5

PMID:40221807

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11993956/

Abstract

BACKGROUND

Recent randomized controlled trials have consistently demonstrated the safety and potential efficacy of MSC therapy for heart failure patients. This study delves into mesenchymal stem cells' promising potential, offering a beacon of hope for the future of heart failure treatment with reduced ejection fraction (HFrEF).

METHODS

We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for this systematic review and meta-analysis. We searched four databases and registers for RCTs, including PubMed, EBSCO, clinicaltrials.gov, ICTRP, and other relevant websites. We then selected thirteen RCTs with 1184 participants based on our pre-defined inclusion/exclusion criteria. Two independent assessors extracted the data and performed a quality assessment. The data were then plotted for various outcomes, including death, hospitalization, major adverse cardiac events, pump function parameters, and 6-min walk distance.

RESULTS

The safety of MSC-based treatment has been consistently demonstrated with MSCs from autologous (MSCs) and allogeneic (MSCs) sources. This reassuring finding underscores the reliability of MSC-based therapy irrespective of their source. However, MSCs showed a trend toward greater protective benefits. Subgroup analysis revealed no significant differences between MSCs and MSCs in improving LVEF; 0.86% (95% CI - 1.21-2.94%) for MSCs versus 2.17% (- 0.48%; 95% CI - 1.33-5.67%) for MSCs. MSCs significantly reduced end-diastolic volume (LVEDV) by - 2.08 mL (95% CI - 3.52-0.64 mL). Only MSCs significantly improved 6-min walking distance (6-MWD); 31.88 m (95% CI 5.03-58.74 m) for MSCs versus 31.71 m (95% CI - 8.91-71.25 m) for MSCs. The exclusion of studies using adipose-derived cells resulted in even better safety and a significant improvement in LVEF for MSCs treatment.

CONCLUSION

Our findings suggest that MSCs are at par with MSCs in improving functional outcomes in heart failure patients. This underscores the need for future investigations in a larger patient cohort, emphasizing the urgency and importance of further research to fully understand the potential of MSCs in treating heart failure.

摘要

背景

近期的随机对照试验一致证明了间充质干细胞（MSC）治疗心力衰竭患者的安全性和潜在疗效。本研究深入探讨了间充质干细胞的巨大潜力，为射血分数降低的心力衰竭（HFrEF）治疗的未来带来了希望之光。

方法

我们遵循系统评价和荟萃分析的首选报告项目指南进行本系统评价和荟萃分析。我们在四个数据库和注册库中检索随机对照试验，包括PubMed、EBSCO、clinicaltrials.gov、ICTRP以及其他相关网站。然后，我们根据预先定义的纳入/排除标准选择了13项随机对照试验，共1184名参与者。两名独立评估人员提取数据并进行质量评估。然后针对各种结果绘制数据，包括死亡、住院、主要不良心脏事件、泵功能参数和6分钟步行距离。

结果

来自自体（MSCs）和异体（MSCs）来源的MSCs一直证明了基于MSC治疗的安全性。这一令人放心的发现强调了基于MSC治疗的可靠性，无论其来源如何。然而，MSCs显示出更大的保护益处趋势。亚组分析显示，在改善左心室射血分数（LVEF）方面，MSCs和MSCs之间没有显著差异；MSCs为0.86%（95%置信区间-1.21至2.94%），而MSCs为2.17%（-0.48%；95%置信区间-1.33至5.67%）。MSCs显著降低舒张末期容积（LVEDV）-2.08 mL（95%置信区间-3.52至0.64 mL）。只有MSCs显著改善了6分钟步行距离（6-MWD）；MSCs为31.88 m（95%置信区间5.03至58.74 m），而MSCs为31.71 m（95%置信区间-8.91至71.25 m）。排除使用脂肪来源细胞的研究后，MSCs治疗的安全性更高，LVEF有显著改善。