期刊
EUROPEAN HEART JOURNAL
卷 36, 期 27, 页码 1744-1753出版社
OXFORD UNIV PRESS
DOI: 10.1093/eurheartj/ehv136
关键词
Mesenchymal stromal cell; Stem cell; Ischaemic heart disease; Heart failure; Clinical trial
资金
- Arvid Nilsson's Foundation
- Aase and Ejnar Danielsen's Foundation
- Augustinus Foundation
- Research Foundation at Rigshospitalet
- Axel Muusfeldt Foundation
- Eva and Henry Fraenkel's Foundation
- Gangsted Foundation
- Vera and Flemming Westerberg's Foundation
- Jeppe and Ovita Juhl's Foundation
- Sophus and Astrid Jacobsen Foundation
Aims Regenerative treatment with mesenchymal stromal cells (MSCs) has been promising in patients with ischaemic heart failure but needs confirmation in larger randomized trials. We aimed to study effects of intra-myocardial autologous bone marrow-derived MSC treatment in patients with severe ischaemic heart failure. Methods and results The MSC-HF trial is a randomized, double-blind, placebo-controlled trial. Patients were randomized 2 : 1 to intra-myocardial injections of MSC or placebo, respectively. The primary endpoint was change in left ventricular end-systolic volume (LVESV), measured by magnetic resonance imaging or computed tomography at 6 months follow-up. Sixty patients aged 30-80 years with severe ischaemic heart failure, New York Heart Association (NYHA) classes II-III, left ventricular ejection fraction (LVEF) < 45% and no further treatment options were randomized. Fifty-five patients completed the 6-month follow-up (37 MSCs vs. 18 placebo). At 6 months, LVESV was reduced in the MSC group: -7.6 (95% CI -11.8 to -3.4) mL (P = 0.001), and increased in the placebo group: 5.4 (95% CI -0.4 to 11.2) mL (P = 0.07). The difference between groups was 13.0 (95% CI 5.9-20.1) mL (P = 0.001). Compared with placebo, there were also significant improvements in LVEF of 6.2% (P < 0.0001), stroke volume of 18.4 mL (P < 0.0001), and myocardial mass of 5.7 g (P = 0.001). No differences were found in NYHA class, 6-min walking test and Kansas City cardiomyopathy questionnaire. No side effects were identified. Conclusion Intra-myocardial injections of autologous culture expanded MSCs were safe and improved myocardial function in patients with severe ischaemic heart failure.
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