Results from the SCIENCE and Danish ASC trials using allogeneic mesenchymal stromal cells to treat ischemic heart failure patients

Abstract

Background and aims: Allogeneic mesenchymal stromal cell (ASC) therapy is a potential treatment option in patients with ischemic heart failure (HF). We aimed to investigate the effect of allogeneic Cardiology Stem Cell Center Adipose tissue derived mesenchymal Stromal Cell product (CSCC_ASC) by joining data from the international SCIENCE and the Danish ASC trial. Methods: Data from two double-blinded placebo-controlled phase II studies including patients with same inclusion and exclusion criteria and identical endpoints were combined. Patients had left ventricular ejection fraction (LVEF) < 45% and New York Heart Association (NYHA) II-III without further treatment options. Results: Two hundred and fourteen patients were randomly assigned to receive CSCC_ASCs or placebo injections. There was no difference in baseline characteristics between groups. No significant differences from baseline to 6-month follow-up were detected between the intervention and placebo-group in left ventricular end-systolic volume, end-diastolic volume or LVEF (p = 0.973, p = 0.601, p = 0.152). The 6-min walking test, NYHA-classification and quality of life score were unchanged in both groups. The difference between groups in N-terminal pro B-type natriuretic peptide and C-reactive protein at 6 months was statistically significant (p = 0.045, p = 0.021). Conclusions: Post-hoc analysis demonstrated that a single intramyocardial CSCC_ASC injection in patients with chronic ischemic no-option HF did not improve cardiac function.