Abstract Body: Introduction: Chronic ischemic heart disease often leads to heart failure, a condition where standard revascularization via coronary artery bypass grafting (CABG) typically results in only modest functional recovery (approximately 5–8%). To address this, we investigated an adjunct therapy utilizing autologous bone marrow aspirate concentrate (BMAC) to promote myocardial repair.
Hypothesis: We assessed the hypothesis that the autologous intramyocardial delivery of bone marrow stem cells during CABG safely improves long-term left ventricular ejection fraction (LVEF) in patients with chronic ischemic heart disease.
Methods: In this prospective, randomized, open-label, unicenter trial (N=24 in the treatment group), bone marrow was aspirated from the patient’s hip (upper iliac crest). The aspirate was processed using the Harvest Technologies SmartPReP2 BMAC System, which utilizes centrifugation to separate red blood cells and remove plasma to prepare the stem cell concentrate. These autologous cells were then delivered via intramyocardial injection into targeted ischemic tissues during the CABG procedure. LVEF was assessed at baseline, 1 week, and >3 years post-operatively.
Results: The patient cohort (N=24) had a mean age of 64.42 +8.25 years and a mean BMI of 28.38+4.05 kg/m². While LVEF showed no significant change at 1 week post-procedure (P=ns), a highly significant improvement was observed at the>3 year follow-up. Mean LVEF increased from approximately 28% at baseline to approximately 45% at the final follow-up (P < 0.001). Functional response was categorized into 4 super-responders (LVEF increase >20%), 7 responders (increase 5–20%), and 8 low-responders (increase <5%).
Conclusions: In conclusion, the intramyocardial transplantation of autologous bone marrow stem cells during CABG is a safe intervention that significantly improves long-term LVEF in patients with chronic ischemic heart disease. These findings suggest that combining surgical revascularization with targeted cell-based therapies offers a superior therapeutic trajectory for heart failure patients compared to surgery alone.

Funding: APVV 23-0557, VEGA 1/0523/25, StemCellPharmacol 401101C023