Myogenic Cardiac Regeneration: Clinical Studies Using Skeletal Myoblasts

Stem cell therapyStem cell therapy offers promising results for repopulating and regenerating damaged myocardium. In this regard, skeletal myoblasts (SkMs)Skeletal myoblasts (SkMs)clinical phase assessment were the first to enter the clinical phase assessment after extensive experimental and translational studies with encouraging data, which paved the way for cell-based therapyCell-based therapy using other cell types. We aim to analyze SkMs-based cell therapy results from phase-II clinical trials in ischemic cardiomyopathy patients and assess the safety and efficacy of SkMs, primarily focusing on the structural and functional indices of the heart, besides the incidence of arrhythmogenicity reports in these trials. A comprehensive literature review was conducted across three databases, analyzing nine eligible phase-II clinical trials involving 247 patients. PatientsSkeletal myoblasts (SkMs)patients were treated with either a placebo or SkMs, and data were analyzed for outcomes including death, adverse events, changes in cardiac function (LVEF), 6-minute walk distance (6-MWD),6-minute walk distance (6-MWD), and NYHA functional class improvement. The study found a mean improvement of 9.85% in LVEF, significantly higher than the placebo group (p < 0.005). 6-MWD improved from 407.5 to 460 (p < 0.001 versus placebo). No deaths were reported in the SkM-treated group. Two patients experienced transplant-related arrhythmias, which were pharmacologically treatable. NYHA functional class improved from three to two in the SkM-treated group. Our critical appraisal of phase-II studies suggests that SkMs-based therapy is safe and effective for heart failure patients, with a low incidence of pharmacologically treatable arrhythmias.