Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial)

Anders Bruun Mathiasen; Abbas Ali Qayyum; Erik Jørgensen; Steffen Helqvist; Anne Fischer-Nielsen; Klaus F Kofoed; Mandana Haack-Sørensen; Annette Ekblond; Jens Kastrup

doi:10.1093/eurheartj/ehv136

Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial)

Anders Bruun Mathiasen, Abbas Ali Qayyum, Erik Jørgensen, Steffen Helqvist, Anne Fischer-Nielsen, Klaus F Kofoed, Mandana Haack-Sørensen, Annette Ekblond, Jens Kastrup

Department of Clinical Medicine

172 Citations (Scopus)

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) <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).

Original language	English
Journal	European Heart Journal
Volume	36
Issue number	27
Pages (from-to)	1744-53
Number of pages	10
ISSN	0195-668X
DOIs	https://doi.org/10.1093/eurheartj/ehv136
Publication status	Published - 14 Jul 2015

Access to Document

10.1093/eurheartj/ehv136

Cite this

Mathiasen, A. B., Qayyum, A. A., Jørgensen, E., Helqvist, S., Fischer-Nielsen, A., Kofoed, K. F., Haack-Sørensen, M., Ekblond, A., & Kastrup, J. (2015). Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial). European Heart Journal, 36(27), 1744-53. https://doi.org/10.1093/eurheartj/ehv136

Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure : a randomized placebo-controlled trial (MSC-HF trial). / Mathiasen, Anders Bruun; Qayyum, Abbas Ali; Jørgensen, Erik et al.

In: European Heart Journal, Vol. 36, No. 27, 14.07.2015, p. 1744-53.

Research output: Contribution to journal › Journal article › Research › peer-review

Mathiasen, AB, Qayyum, AA, Jørgensen, E, Helqvist, S, Fischer-Nielsen, A , Kofoed, KF, Haack-Sørensen, M, Ekblond, A & Kastrup, J 2015, 'Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial)', European Heart Journal, vol. 36, no. 27, pp. 1744-53. https://doi.org/10.1093/eurheartj/ehv136

@article{74c4339d9a154706a6678bd1098cdb91,

title = "Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial)",

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) <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).",

author = "Mathiasen, {Anders Bruun} and Qayyum, {Abbas Ali} and Erik J{\o}rgensen and Steffen Helqvist and Anne Fischer-Nielsen and Kofoed, {Klaus F} and Mandana Haack-S{\o}rensen and Annette Ekblond and Jens Kastrup",

year = "2015",

month = jul,

day = "14",

doi = "10.1093/eurheartj/ehv136",

language = "English",

volume = "36",

pages = "1744--53",

journal = "European Heart Journal",

issn = "0195-668X",

publisher = "Oxford University Press",

number = "27",

}

TY - JOUR

T1 - Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure

T2 - a randomized placebo-controlled trial (MSC-HF trial)

AU - Mathiasen, Anders Bruun

AU - Qayyum, Abbas Ali

AU - Jørgensen, Erik

AU - Helqvist, Steffen

AU - Fischer-Nielsen, Anne

AU - Kofoed, Klaus F

AU - Haack-Sørensen, Mandana

AU - Ekblond, Annette

AU - Kastrup, Jens

PY - 2015/7/14

Y1 - 2015/7/14

N2 - 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).

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).

U2 - 10.1093/eurheartj/ehv136

DO - 10.1093/eurheartj/ehv136

M3 - Journal article

C2 - 25926562

SN - 0195-668X

VL - 36

SP - 1744

EP - 1753

JO - European Heart Journal

JF - European Heart Journal

IS - 27

ER -

Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial)

Abstract

Access to Document

Fingerprint

Cite this