Safety and Efficacy of Adipose-Derived Mesenchymal Stem Cell Therapy for Ischemic Heart Disease: A Systematic Review.

Fernando Rabioglio Giugni, Melina de Oliveira Valdo Giugni, Henrique Trombini Pinesi, Fabio Cetinic Habrum, Lígia Nasi Laranjeira, Erica Regina Ribeiro Sady, Erica Aranha Suzumura, Luis Henrique Wolff Gowdak, José Eduardo Krieger
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Abstract

Background: Cell therapy using adipose-derived mesenchymal stem cells (ADSCs) shows great potential as a treatment for cardiovascular diseases.

Objective: We conducted a systematic review to describe the safety and efficacy of ADSCs in ischemic heart disease.

Methods: We searched PubMed/MEDLINE, EMBASE, Web of Science, CENTRAL, and LILACS (from inception to March 2024) for clinical studies involving ADSCs in patients with ischemic heart disease. We excluded studies involving patients with other types of heart disease, studies using mesenchymal stem cells derived from other tissues, as well as ongoing studies. Two independent reviewers screened the retrieved citations, extracted relevant data, and assessed the risk of bias in the included trials, using the Cochrane Collaboration criteria modified by McMaster University and Methodological Index for Non-Randomized Studies (MINORS). We used a narrative synthesis to present the results.

Results: Ten studies (comprising 29 publications) met our inclusion criteria, including 8 randomized controlled trials and 2 uncontrolled trials. No severe adverse events associated with ADSC therapy were reported. While most efficacy endpoints did not reach statistical significance, there were reports of improved ischemic area, functional capacity, symptoms, and contractility in patients treated with ADSCs.

Conclusions: The findings from our review suggest that ADSC therapy is generally safe for patients with ischemic heart disease. However, further investigation is warranted to confirm its efficacy, particularly with larger clinical trials and in specific conditions where improvements in microcirculation may have a notable impact on clinical outcomes.

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脂肪间充质干细胞疗法治疗缺血性心脏病的安全性和有效性:系统回顾
背景:利用脂肪来源间充质干细胞(ADSCs)进行细胞治疗作为心血管疾病的治疗方法具有巨大潜力:我们进行了一项系统性综述,以描述 ADSCs 治疗缺血性心脏病的安全性和有效性:我们检索了 PubMed/MEDLINE、EMBASE、Web of Science、CENTRAL 和 LILACS(从开始到 2024 年 3 月)中涉及缺血性心脏病患者 ADSCs 的临床研究。我们排除了涉及其他类型心脏病患者的研究、使用其他组织间充质干细胞的研究以及正在进行的研究。两位独立审稿人筛选了检索到的引文,提取了相关数据,并采用经麦克马斯特大学和非随机研究方法索引(MINORS)修订的科克伦协作组标准评估了纳入试验的偏倚风险。我们采用叙事综合法来呈现结果:10项研究(包括29篇论文)符合我们的纳入标准,其中包括8项随机对照试验和2项非对照试验。没有与 ADSC 治疗相关的严重不良事件的报道。虽然大多数疗效终点未达到统计学意义,但有报道称接受 ADSCs 治疗的患者缺血面积、功能能力、症状和收缩力均有所改善:我们的研究结果表明,ADSC疗法对缺血性心脏病患者总体上是安全的。结论:我们的综述结果表明,ADSC疗法对缺血性心脏病患者总体上是安全的,但仍需进一步研究以确认其疗效,特别是在微循环改善可能对临床结果产生显著影响的特定情况下进行更大规模的临床试验。
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