This is a phase I/IIa study to investigate the safety, tolerability, and preliminary effectiveness of HeXell-2020 in patients with stable coronary artery disease (CAD). HeXell-2020 is an investigational drug product consisting of allogenic umbilical cord mesenchymal stem cells (UCMSCs) as the drug substance. All enrolled and eligible subjects will receive HeXell-2020 treatment.
Subject who is able to understand the nature of this study and accepts to enter the study by signing written informed consent
Male or female who are aged between 18 and 75 years old on date of consent
Patient without LV thrombus or ventricular aneurysm documented by echocardiography at screening
Patient having a diagnosis of CAD caused by ≥ 50% stenosis of at least 1 major or larger epicardial coronary artery (target vessel ≥ 2 mm in diameter without in-stent restenosis) documented by imaging studies within 12 months prior to the date of dosing. If the stenosis results are derived from CCTA, the examination time of CCTA should be at least 6 months prior to screening.
Subject had participated in investigational drug trials and took any investigational drugs within 28 days prior to the first treatment.
Coronary artery bypass grafting (CABG)
Valve repair/replacement
Cardiac resynchronization therapy (CRT) device