PMID- 25926562 OWN - NLM STAT- MEDLINE DCOM- 20160425 LR - 20220317 IS - 1522-9645 (Electronic) IS - 0195-668X (Linking) VI - 36 IP - 27 DP - 2015 Jul 14 TI - Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial). PG - 1744-53 LID - 10.1093/eurheartj/ehv136 [doi] AB - 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. STUDY REGISTRATION NUMBER: NCT00644410 (ClinicalTrials.gov). CI - Published on behalf of the European Society of Cardiology. All rights reserved. (c) The Author 2015. For permissions please email: journals.permissions@oup.com. FAU - Mathiasen, Anders Bruun AU - Mathiasen AB AD - Cardiac Catheterization Laboratory 2014 and Cardiology Stem Cell Laboratory, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark abbe@dadlnet.dk. FAU - Qayyum, Abbas Ali AU - Qayyum AA AD - Cardiac Catheterization Laboratory 2014 and Cardiology Stem Cell Laboratory, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark. FAU - Jorgensen, Erik AU - Jorgensen E AD - Cardiac Catheterization Laboratory 2014 and Cardiology Stem Cell Laboratory, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark. FAU - Helqvist, Steffen AU - Helqvist S AD - Cardiac Catheterization Laboratory 2014 and Cardiology Stem Cell Laboratory, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark. FAU - Fischer-Nielsen, Anne AU - Fischer-Nielsen A AD - Department of Clinical Immunology 2034, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. FAU - Kofoed, Klaus F AU - Kofoed KF AD - Cardiac Catheterization Laboratory 2014 and Cardiology Stem Cell Laboratory, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark Department of Radiology, Diagnostic Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. FAU - Haack-Sorensen, Mandana AU - Haack-Sorensen M AD - Cardiac Catheterization Laboratory 2014 and Cardiology Stem Cell Laboratory, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark. FAU - Ekblond, Annette AU - Ekblond A AD - Cardiac Catheterization Laboratory 2014 and Cardiology Stem Cell Laboratory, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark. FAU - Kastrup, Jens AU - Kastrup J AD - Cardiac Catheterization Laboratory 2014 and Cardiology Stem Cell Laboratory, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark. LA - eng SI - ClinicalTrials.gov/NCT00644410 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150429 PL - England TA - Eur Heart J JT - European heart journal JID - 8006263 SB - IM CIN - Nat Rev Cardiol. 2015 Jul;12(7):382. PMID: 25985869 CIN - Eur Heart J. 2015 Jul 14;36(27):1711-3. PMID: 26022009 CIN - Cardiovasc Diagn Ther. 2017 Jun;7(3):E4-E6. PMID: 28567365 CIN - Cardiovasc Diagn Ther. 2017 Jun;7(Suppl 2):S69-S72. PMID: 28748151 MH - Adult MH - Aged MH - Aged, 80 and over MH - Cardiac Imaging Techniques/methods MH - Double-Blind Method MH - Female MH - Heart Failure/*therapy MH - Humans MH - Injections, Intralesional MH - Magnetic Resonance Angiography MH - Male MH - Mesenchymal Stem Cell Transplantation/*methods MH - Middle Aged MH - Myocardial Ischemia/*therapy MH - Quality of Life MH - Tomography, X-Ray Computed OTO - NOTNLM OT - Clinical trial OT - Heart failure OT - Ischaemic heart disease OT - Mesenchymal stromal cell OT - Stem cell EDAT- 2015/05/01 06:00 MHDA- 2016/04/26 06:00 CRDT- 2015/05/01 06:00 PHST- 2014/08/11 00:00 [received] PHST- 2015/04/02 00:00 [accepted] PHST- 2015/05/01 06:00 [entrez] PHST- 2015/05/01 06:00 [pubmed] PHST- 2016/04/26 06:00 [medline] AID - ehv136 [pii] AID - 10.1093/eurheartj/ehv136 [doi] PST - ppublish SO - Eur Heart J. 2015 Jul 14;36(27):1744-53. doi: 10.1093/eurheartj/ehv136. Epub 2015 Apr 29.