The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre\_adipose derived stem cells (CSCC\_ASCs) in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.
The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre\_adipose derived stem cells (CSCC\_ASCs) in patients with reduced left ventricular EF (≤45%) and heart failure. The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC\_ASCs in patients with reduced left ventricular EF (≤45%) and heart failure in a double-blind placebo-controlled design. A total of 138 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC\_ASC or placebo (saline).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
133
The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, Denmark
left ventricle end-systolic volume (LVESV)
The primary endpoint is change in left ventricle end-systolic volume (LVESV) from baseline to 6 months follow-up measured by ECHO, MR and CT between CSCC\_ASC and placebo treated
Time frame: 6 months
Safety - Serious adverse events
Incidence and severity of serious adverse events and suspected unrelated serious adverse events 12 months follow-up
Time frame: 6 months
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