Results from the SCIENCE and Danish ASC trials using allogeneic mesenchymal stromal cells to treat ischemic heart failure patients.

IF 3 4区医学 Q4 CELL & TISSUE ENGINEERING

Regenerative medicine Pub Date : 2025-11-01 Epub Date: 2025-10-14 DOI:10.1080/17460751.2025.2574194

Nadia Chaaban, Jens Kastrup, Abbas Ali Qayyum

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Abstract

Background and aims: Allogeneic mesenchymal stromal cell (ASC) therapy is a potential treatment option in patients with ischemic heart failure (HF). We aimed to investigate the effect of allogeneic Cardiology Stem Cell Center Adipose tissue derived mesenchymal Stromal Cell product (CSCC_ASC) by joining data from the international SCIENCE and the Danish ASC trial.

Methods: Data from two double-blinded placebo-controlled phase II studies including patients with same inclusion and exclusion criteria and identical endpoints were combined. Patients had left ventricular ejection fraction (LVEF) < 45% and New York Heart Association (NYHA) II-III without further treatment options.

Results: Two hundred and fourteen patients were randomly assigned to receive CSCC_ASCs or placebo injections. There was no difference in baseline characteristics between groups.No significant differences from baseline to 6-month follow-up were detected between the intervention and placebo-group in left ventricular end-systolic volume, end-diastolic volume or LVEF (p = 0.973, p = 0.601, p = 0.152). The 6-min walking test, NYHA-classification and quality of life score were unchanged in both groups. The difference between groups in N-terminal pro B-type natriuretic peptide and C-reactive protein at 6 months was statistically significant (p = 0.045, p = 0.021).

Conclusions: Post-hoc analysis demonstrated that a single intramyocardial CSCC_ASC injection in patients with chronic ischemic no-option HF did not improve cardiac function.

Abstract Image

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来自SCIENCE和丹麦ASC试验的结果，使用同种异体间充质基质细胞治疗缺血性心力衰竭患者。

背景和目的：同种异体间充质间质细胞（ASC）治疗是缺血性心力衰竭（HF）患者的一种潜在治疗选择。我们的目的是通过结合国际SCIENCE和丹麦ASC试验的数据，研究同种异体心脏病干细胞中心脂肪组织衍生间充质间质细胞产品（CSCC_ASC）的作用。方法：合并两项双盲安慰剂对照II期研究的数据，纳入和排除标准相同、终点相同的患者。结果：214例患者被随机分配接受CSCC_ASCs或安慰剂注射。两组间基线特征无差异。干预组与安慰剂组左室收缩末期容积、舒张末期容积、LVEF从基线到随访6个月无显著差异（p = 0.973, p = 0.601, p = 0.152）。两组患者6分钟步行测试、nyha分级和生活质量评分均无变化。6个月时n端前b型利钠肽、c反应蛋白组间差异有统计学意义（p = 0.045, p = 0.021）。结论：事后分析表明，慢性缺血性无选择心力衰竭患者单次心肌内注射CSCC_ASC并没有改善心功能。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Regenerative medicine 医学-工程：生物医学

CiteScore

4.20

自引率

3.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function*. Since 2006, Regenerative Medicine has been at the forefront of publishing the very best papers and reviews covering the entire regenerative medicine sector. The journal focusses on the entire spectrum of approaches to regenerative medicine, including small molecule drugs, biologics, biomaterials and tissue engineering, and cell and gene therapies – it’s all about regeneration and not a specific platform technology. The journal’s scope encompasses all aspects of the sector ranging from discovery research, through to clinical development, through to commercialization. Regenerative Medicine uniquely supports this important area of biomedical science and healthcare by providing a peer-reviewed journal totally committed to publishing the very best regenerative medicine research, clinical translation and commercialization. Regenerative Medicine provides a specialist forum to address the important challenges and advances in regenerative medicine, delivering this essential information in concise, clear and attractive article formats – vital to a rapidly growing, multidisciplinary and increasingly time-constrained community. Despite substantial developments in our knowledge and understanding of regeneration, the field is still in its infancy. However, progress is accelerating. The next few decades will see the discovery and development of transformative therapies for patients, and in some cases, even cures. Regenerative Medicine will continue to provide a critical overview of these advances as they progress, undergo clinical trials, and eventually become mainstream medicine.