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19-12-2018 | Original Article | Uitgave 2/2019 Open Access

Netherlands Heart Journal 2/2019

Intramyocardial bone marrow cell injection does not lead to functional improvement in patients with chronic ischaemic heart failure without considerable ischaemia

Tijdschrift:
Netherlands Heart Journal > Uitgave 2/2019
Auteurs:
I. Mann, C. C. S. Tseng, S. F. Rodrigo, S. Koudstaal, J. van Ramshorst, S. L. Beeres, P. Dibbets-Schneider, L. F. de Geus-Oei, H. J. Lamb, R. Wolterbeek, J. J. Zwaginga, W. E. Fibbe, K. Westinga, J. J. Bax, P. A. Doevendans, M. J. Schalij, S. A. J. Chamuleau, D. E. Atsma
Belangrijke opmerkingen

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s12471-018-1213-2) contains supplementary material, which is available to authorized users.
I. Mann and C.C.S. Tseng contributed equally to this work.

Abstract

Background

It has been suggested that bone marrow cell injection may have beneficial effects in patients with chronic ischaemic heart disease. However, previous trials have led to discrepant results of cell-based therapy in patients with chronic heart failure. The aim of this study was to evaluate the efficacy of intramyocardial injection of mononuclear bone marrow cells in patients with chronic ischaemic heart failure with limited stress-inducible myocardial ischaemia.

Methods and results

This multicentre, randomised, placebo-controlled trial included 39 patients with no-option chronic ischaemic heart failure with a follow-up of 12 months. A total of 19 patients were randomised to autologous intramyocardial bone marrow cell injection (cell group) and 20 patients received a placebo injection (placebo group). The primary endpoint was the group difference in change of left ventricular ejection fraction, as determined by single-photon emission tomography. On follow-up at 3 and 12 months, change of left ventricular ejection fraction in the cell group was comparable with change in the placebo group (P = 0.47 and P = 0.08, respectively). Also secondary endpoints, including left ventricle volumes, myocardial perfusion, functional and clinical parameters did not significantly change in the cell group as compared to placebo. Neither improvement was demonstrated in a subgroup of patients with stress-inducible ischaemia (P = 0.54 at 3‑month and P = 0.15 at 12-month follow-up).

Conclusion

Intramyocardial bone marrow cell injection does not improve cardiac function, nor functional and clinical parameters in patients with severe chronic ischaemic heart failure with limited stress-inducible ischaemia.
Clinical Trial Registration: NTR2516

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Netherlands Heart Journal

Het Netherlands Heart Journal wordt uitgegeven in samenwerking met de Nederlandse Vereniging voor Cardiologie en de Nederlandse Hartstichting. Het tijdschrift is Engelstalig en wordt gratis beschikbaa ...

Extra materiaal
Supplementary Table 1 Severe adverse events
12471_2018_1213_MOESM1_ESM.docx
Supplementary Table 2 Clinical and functional status
12471_2018_1213_MOESM2_ESM.docx
Supplementary Table 3 Effect of cell therapy on myocardial perfusion in randomised clinical trials
12471_2018_1213_MOESM3_ESM.docx
Literatuur
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