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

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 t...

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Published in:Netherlands heart journal 2019-02, Vol.27 (2), p.81-92
Main Authors: Mann, I., Tseng, C. C. S., Rodrigo, S. F., Koudstaal, S., van Ramshorst, J., Beeres, S. L., Dibbets-Schneider, P., de Geus-Oei, L. F., Lamb, H. J., Wolterbeek, R., Zwaginga, J. J., Fibbe, W. E., Westinga, K., Bax, J. J., Doevendans, P. A., Schalij, M. J., Chamuleau, S. A. J., Atsma, D. E.
Format: Article
Language:English
Subjects:
Adenosine
Angina pectoris
Bone marrow
Cardiac function
Cardiology
Cardiovascular disease
Catheters
Coronary vessels
Heart attacks
Heart failure
HIV
Human immunodeficiency virus
Ischemia
Laboratories
Medical Education
Medicine
Medicine & Public Health
Original
Original Article
Patients
Stem cells
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Summary: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
ISSN:1568-5888
1876-6250
DOI:10.1007/s12471-018-1213-2