Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial)
Top Cited Papers
- 29 April 2015
- journal article
- research article
- Published by Oxford University Press (OUP) in European Heart Journal
- Vol. 36 (27), 1744-1753
- https://doi.org/10.1093/eurheartj/ehv136
Abstract
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) 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% (PP < 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. Study registration number NCT00644410 (ClinicalTrials.gov).Keywords
This publication has 29 references indexed in Scilit:
- Cell therapy for human ischemic heart diseases: Critical review and summary of the clinical experiencesJournal of Molecular and Cellular Cardiology, 2014
- A critical analysis of clinical outcomes reported in stem cell trials for acute myocardial infarction: some thoughts for design of future trials.Current Atherosclerosis Reports, 2013
- Mesenchymal Stromal Cell Phenotype is not Influenced by Confluence during Culture ExpansionStem Cell Reviews and Reports, 2012
- Long-Term Effects of Autologous Bone Marrow Stem Cell Treatment in Acute Myocardial Infarction: Factors That May Influence OutcomesPLOS ONE, 2012
- Mesenchymal stromal cells affect cardiomyocyte growth through juxtacrine Notch-1/Jagged-1 signaling and paracrine mechanisms: Clues for cardiac regenerationJournal of Molecular and Cellular Cardiology, 2011
- Human mesenchymal stem cell-conditioned medium improves cardiac function following myocardial infarctionStem Cell Research, 2011
- Mesenchymal stromal cell derived endothelial progenitor treatment in patients with refractory anginaScandinavian Cardiovascular Journal, 2011
- Bone Marrow Mesenchymal Stem Cells Stimulate Cardiac Stem Cell Proliferation and DifferentiationCirculation Research, 2010
- Mesenchymal stromal cells for cardiovascular repair: current status and future challengesFuture Cardiology, 2009
- Paracrine Mechanisms in Adult Stem Cell Signaling and TherapyCirculation Research, 2008