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Bone-marrow-derived cells for cardiac stem cell therapy: safe or still under scrutiny?

Abstract

Cardiac stem cell therapy with bone-marrow-derived stem cells is a promising approach to facilitate myocardial regeneration after acute myocardial infarction or in congestive heart failure. The clinical data currently available seem to indicate that this approach is safe and is not associated with an increase in the number of adverse clinical events; nevertheless, the level of safety confidence is limited because of the small number of patients who have been treated and the absence of long-term clinical follow-up data. In order to establish the clinical safety of cardiac stem cell therapy, it will be necessary to collect additional data from both previous and ongoing clinical trials in subsets of patients relative to their background risk. Several conceptual safety concerns should also be addressed. These concerns relate to a number of operational mechanisms and include biological effects on differentiation, remote homing of transplanted stem cells, progression of atherosclerosis, and arrhythmias. The proactive scrutiny of these phenomena could eventually facilitate the translation of the promise of cardiac regeneration into a safe and effective therapy.

Key Points

  • The clinical data currently available indicate that cardiac stem cell therapy is safe

  • The level of safety confidence is limited, however, because of the small number of patients who have been treated and the absence of long-term clinical follow-up data

  • Several conceptual safety concerns should be addressed, including operational mechanisms (e.g. inappropriate myocardial biologic effects), remote homing of transplanted stem cells, controversy regarding progression of atherosclerosis, and arrhythmias

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Figure 1: Factors related to clinical safety of stem cell therapy
Figure 2: Stem cell processing does not activate inflammatory signals

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Acknowledgements

We acknowledge the contribution of Drs Samer Mansour, Steven Vercauteren, and Giovanna Sarno to our clinical studies on coronary cell transfer. We also thank Dr Ike Lee for thoughtful comments on the manuscript.

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Correspondence to Jozef Bartunek.

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Competing interests

J Bartunek, W Wijns, G Heyndrickx, and M Vanderheyden are members of a non-profit organization which is a founding member of Cardio3, a start-up company. F Timmermans, B Vandekerkhove, A Villa, PL Sanchez, R Arnold, JA San Roman, and F Fernandez-Aviles declared they have no competing interests.

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Bartunek, J., Vanderheyden, M., Wijns, W. et al. Bone-marrow-derived cells for cardiac stem cell therapy: safe or still under scrutiny?. Nat Rev Cardiol 4 (Suppl 1), S100–S105 (2007). https://doi.org/10.1038/ncpcardio0744

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