Level A· Stronger Clinical EvidenceRandomized Controlled Trial

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

Chaaban N., Kastrup J., Qayyum AA.

Randomized Controlled Trial with a reported sample of 214 on Cardiovascular Disease, published in Regen Med (2025) — summary generated from the PubMed abstract.

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Study type
Randomized Controlled Trial
Journal
Regen Med (2025)
Country
England
Reported sample size
214
PMID
41084786
DOI
10.1080/17460751.2025.2574194

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

What this study does not prove

  • This study does not prove SVF is an approved treatment or a replacement for standard care.

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.

How we grade evidence
HumansHeart FailureMaleFemaleMesenchymal Stem Cell TransplantationMyocardial IschemiaMiddle AgedMesenchymal Stem CellsAgedDenmark

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