This study will evaluate if the VB-C01 cellularised patch, a collagen membrane seeded with allogeneic adipose-derived stem cells, is safe and effective for surgical epicardial implantation in patients undergoing coronary artery bypass grafting (CABG) who are at high risk of developing heart failure. Researchers will enroll 10 participants in this phase I open-label clinical trial.
The intervention involves the surgical epicardial placement of the collagen membrane seeded with adipose-derived stem cells during coronary revascularisation surgery. The primary outcome measured will be the combination of major adverse cardiac and cerebrovascular events (MACCEs) at follow-up visits through the first year after treatment, specifically at postoperative intervals of 1, 3, 6, 9, and 12 months. MACCEs include all-cause death, myocardial infarction requiring target vessel revascularisation, hospitalisation for heart failure, cardiac tamponade or pericardial constriction, sustained ventricular tachycardia, ventricular fibrillation, and stroke.
Secondary outcomes will similarly assess safety through composite MACCEs at the same follow-up intervals over the 12-month timeframe. Researchers will also investigate efficacy by evaluating reductions in myocardial scar size and improvements in ventricular function. They expect to finish the trial in June of 2027.
Link to trial:
https://clinicaltrials.gov/study/NCT06956807
