The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem Cell Centre - Adipose Stem Cells (CSCC\_ASC) study in heart failure patients to investigate the regenerative capacity of the CSCC\_ASC treatment.
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 Ejection Fraction (EF) (≤45%) and heart failure in a double-blind placebo-controlled design. A total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC\_ASC or placebo (saline). The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
81
Direct intramyocardial injection of CSCC\_ASC
Saline
Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet
Copenhagen Ø, Denmark
change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography
change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events
Safety is evaluated by the incidence and severity of serious adverse events and suspected unrelated serious adverse events at 12 months follow-up
Time frame: 12 months
Efficacy left ventricle
change in left ventricle ejection fraction (EF) measured by echocardiography and computerized tomography
Time frame: 6 months
Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up
change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up
Time frame: 6 months
Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up
change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up
Time frame: 6 months
Efficacy clinical function assessed by change in 6 min walking test from baseline to 6 months follow-up
change in 6 min walking test from baseline to 6 months follow-up
Time frame: 6 months
Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up
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change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up
Time frame: 12 months
Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up
change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up
Time frame: 12 months
Efficacy clinical function assessed by change in 6 min walking test from baseline to 12 months follow-up
change in 6 min walking test from baseline to 12 months follow-up
Time frame: 12 months