Kwo Chang Ueng*, Chin Feng Tsai, Chun-Hung Su, Yao Tsung Chuang and Jackson TK Liu
Background: Despite advancements in cardiovascular treatments, Acute Myocardial Infarction (AMI) remains a
significant health challenge. We aimed to explore the potential of stem cell therapy to improve left ventricular
function post-AMI through an open-label, dose-escalating trial. The study aimed to assess the safety and feasibility
of intravenous infusion of MiSaver, a prefabricated product of ABO matched allogeneic umbilical cord blood stem
cells (USC), in patients following recent AMI.
Methods: Participants were enrolled in cohorts of five, receiving escalating dosages of USC (0.5 × 10^7, 1.6 × 10^7,
and 5.0 × 10^7 cells/kg). Infusions were administered 2-5 days post-AMI onset. Due to recruitment challenges during
the COVID-19 pandemic, this retrospective analysis was conducted using completed low and middle dosage groups
and a control group comprising 20 eligible participants meeting similar inclusion criteria.
Results: The primary analysis focused on safety and adverse events (AEs) over a 12-month observational period in
the treatment group. The treatment was well-tolerated, with no AEs directly attributed to MiSaver. Initial analysis of
9 participants showed statistically significant improvements in Left Ventricular Ejection Fraction (LVEF) from baseline
to 12 months post-treatment compared to the control group (p<0.05); however, significance was lost upon inclusion
of participant 10. This participant drew attention to the analysis and exhibited unique characteristics, namely the
highest Body Mass Index (BMI) and the youngest age among all participants.
Conclusion: This study suggests the potential of MiSaver in enhancing left ventricular function post-AMI. Notably,
participants without morbid obesity showed significant recovery in LVEF, suggesting the exclusion of individuals with
high BMI in future trials. Larger cohorts and controlled placebo studies are warranted to validate these findings and
address trial limitations.
Published Date: 2024-06-05; Received Date: 2024-05-08
