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

• Published in: Netherlands heart journal Vol. 27; no. 2; pp. 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: Journal Article
• Language: English
• Published: Houten Bohn Stafleu van Loghum 01.02.2019; Springer Nature B.V
• 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; New York; United States > US; Ischaemia; Chronic heart failure; Bone marrow cells
• DOI: 10.1007/s12471-018-1213-2
• ISSN: 1568-5888

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