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

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

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. 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. 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). Post-hoc analysis demonstrated that a single intramyocardial CSCC_ASC injection in patien

Evidence level

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

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