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. 2019 Feb;27(2):81-92.
doi: 10.1007/s12471-018-1213-2.

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

I Mann  1 , C C S Tseng  2 , S F Rodrigo  1 , S Koudstaal  2 , J van Ramshorst  1 , S L Beeres  1 , P Dibbets-Schneider  3 , L F de Geus-Oei  3   4 , H J Lamb  3 , R Wolterbeek  5 , J J Zwaginga  6 , W E Fibbe  6 , K Westinga  7 , J J Bax  1 , P A Doevendans  2 , M J Schalij  1 , S A J Chamuleau  2 , D E Atsma  8
Affiliations

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

I Mann et al. Neth Heart J. 2019 Feb.

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.

Keywords: Bone marrow cells; Chronic heart failure; Ischaemia.

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Conflict of interest statement

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 and D.E. Atsma declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Patient flow diagram. (CABG coronary artery bypass grafting)
Fig. 2
Fig. 2
Change in left ventricular ejection fraction and volumes. Mean estimated changes at 3‑month and 12-month follow-up in left ventricular ejection fraction at rest (above) and end-systolic and end-diastolic volumes. Bars represent 95% confidence intervals. The treatment effect (difference in changes between bone marrow cell injection group and placebo group) is not significant
Fig. 3
Fig. 3
Change in NYHA score and quality of life. Mean estimated changes on follow-up at 3, 6 and 12 months in NYHA score and on follow-up at 3 and 6 months in MLHF score. Bars represent 95% confidence intervals. The treatment effect (difference in changes between bone marrow cell injection group and placebo group) is not significant, as shown by P-values. (NYHA New York Heart Association, MLHF Minnesota living with heart failure questionnaire)
See this image and copyright information in PMC

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