The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration of placebo during the sham procedure.
It is planned to enroll 105 patients into AMI trial with randomization into active (CardioCell) therapy and sham procedure/placebo administration with 2:1 ratio. Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early uptake and retention of IMP in the target ischemic tissues. The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with AMI. There are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe and way of CardioCell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Patients in the AMI trial will receive one dose of IMP during the index procedure. The IMP administration will be performed by dedicated catheter into infarct related artery. Active IMP consist of 30 000 000 of Wharton's jelly mesenchymal stem cells (WJMSCs) in each IMP dose prepared for patients randomized into active treatment group.
Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner. Control group will receive the same amount of fluid used for WJMSCs preparation, without cells.
The John Paul II Hospital
Krakow, Poland
Central Clinical Hospital of the MSWiA in Warsaw
Warsaw, Poland
Reduction of infarct size
Reduction of infarct size assessed in cardiac MRI during index hospitalization and in 6 month FU between two groups (active vs sham).
Time frame: Index hospitalization and in 6 month FU
Infarct size reduction
Infarct size reduction in SPECT.
Time frame: 6 month FU
Myocardial perfusion improvement
Myocardial perfusion improvement assessed in SPECT.
Time frame: 6 month FU
Myocardial perfusion improvement
Myocardial perfusion improvement assessed in cardiac MRI.
Time frame: 6 month FU
Increase of left ventricle ejection fraction (LVEF)
Increase of left ventricle ejection fraction (LVEF) assessed in cardiac MRI.
Time frame: 6 month FU
Increase of left ventricle ejection fraction (LVEF)
Increase of left ventricle ejection fraction (LVEF) assessed in SPECT.
Time frame: 6 month FU
Left ventricle ejection fraction (LVEF) change against baseline.
Left ventricle ejection fraction (LVEF) change (in %) against baseline, assessed in echocardiography.
Time frame: 6 month FU
Left ventricle end-systolic volume (ESV) change against baseline.
Left ventricle end-systolic volume (ESV, in ml) change against baseline, assessed in echocardiography
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Time frame: 6 month FU
Left ventricle end-diastolic volume (EDV) change against baseline.
Left ventricle end-diastolic volume (EDV, in ml) change against baseline, assessed in echocardiography.
Time frame: 6 month FU
The occurrence of major adverse cardiovascular events
The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure).
Time frame: 1 year FU
Quality of life improvement
Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population.
Time frame: 6 month and 1 year FU.