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Intramyocardial bone marrow cell injection does not lead to functional improvement in patients with chronic ischaemic
I Mann1, C C S Tseng2, S F Rodrigo1
1Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Insights
Bone marrow cell injection did not improve cardiac function in patients with chronic ischemic heart failure. This study found no significant benefits compared to placebo for heart function or clinical outcomes.
Area of Science:
- Cardiology
- Regenerative Medicine
- Cell Therapy
Background:
- Previous studies on bone marrow cell therapy for chronic heart failure yielded inconsistent results.
- Chronic ischemic heart disease patients often have limited treatment options.
Purpose of the Study:
- To assess the efficacy of intramyocardial injection of mononuclear bone marrow cells.
- To evaluate treatment effects in patients with chronic ischemic heart failure and limited stress-inducible ischemia.
Main Methods:
- A multicenter, randomized, placebo-controlled trial involving 39 patients.
- Patients received either autologous bone marrow cell injection or placebo.
- Left ventricular ejection fraction (LVEF) was the primary endpoint, assessed by SPECT over 12 months.
Main Results:
- No significant difference in LVEF change between the cell and placebo groups at 3 and 12 months (P=0.47 and P=0.08).
- Secondary endpoints, including ventricular volumes and myocardial perfusion, also showed no significant improvement.
- A subgroup analysis of patients with stress-inducible ischemia revealed no benefit.
Conclusions:
- Intramyocardial bone marrow cell injection is ineffective for improving cardiac function in severe chronic ischemic heart failure.
- The therapy did not lead to improvements in functional or clinical parameters in the studied patient group.
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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