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
Sequential
HeXell-2020
DrugPhase I Cohort 1: HeXell-2020 with a total of 3 doses, 9x10\^7 cells/dose. Phase I Cohort 2: HeXell-2020 with a total of 6 doses, 9x10\^7 cells/dose. Phase IIa: RP2D from phase I.
Incidence of TEAE, SAE and SUSAR over the study
To evaluate the number of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), suspected and unexpected serious adverse reactions (SUSARs) over the study period,
To determine the recommended phase II dose (RP2D) in Phase I study
To determination RP2D, number and proportion of subjects having experienced DLTs will be presented and the RP2D should be determined on the indicated dose at which ≤ 1 patient experiences DLT out of 6 patients who have been DLT evaluated.
Change in myocardial perfusion defect severity under the rest acquisition and pharmacological stress of dipyridamole in Phase IIa study
Measured by SPECT with thallium-201 from baseline. The SRS, SSS and SDS are three variables used to measure cardiac perfusion and ischemia.
Time to the first occurrence of major adverse cardiovascular events (MACEs)
Including AMI, stroke, cardiovascular mortality, and hospitalization for unstable angina or revascularization procedures, from the date of the first treatment will be analyzed by Kaplan-Meier method.
Change in the evaluation result of CCTA from baseline
The stenosis percent of the different coronary segments, using the 17-segment model.
Change from baseline in echocardiographic measures.
Ventricular remodeling: including LVEF in percentage, global longitudinal strain (GLS) in percentage.
Change in functional class of angina by using CCS angina classification from baseline.
Change in functional class of angina by using CCS angina classification will be summarized descriptively by visit
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