A Phase 2/3 interventional study of CardioCell and Placebos in Heart Failure, sponsored by John Paul II Hospital, Krakow. Completed at 5 sites in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-09.
Sponsored by John Paul II Hospital, Krakow · Phase 2/3, Interventional, and Treatment
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 receive the placebo.
The CIHF trial will enroll 105 patients with randomization into active and placebo therapy 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 myocardial uptake and retention of IMP.
The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with CIHF. There are several secondary questions, defined by secondary endpoints in each cohort, e.g.: if the investigated treatment is possible to administered, if the investigated treatment and way of CardioCell administration is safe, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.
Exclusion Criteria:
Patients randomized to the active treatment group: Transcoronary or trans-bypass graft administration of CardioCell consist 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin) will be performed using a dedicated cell delivery catheter. The cell delivery catheter is a typical coronary balloon catheter that is CE marked (1.2x10 mm balloon, RX system) modified to include cell delivery perforations in the balloon section of the catheter. The cell delivery catheter has been demonstrated not to affect cell viability or other cell properties.
Drug: CardioCell
Patients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.
Drug: Placebos
Patients randomized to the active treatment group will receive transcoronary or trans-bypass graft administration of 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin). Injection will be performed using a dedicated cell delivery catheter. The cell delivery catheter is a typical coronary balloon catheter that is CE marked (1.2x10 mm balloon, RX system) modified to include cell delivery perforations in the balloon section of the catheter. The cell delivery catheter has been demonstrated not to affect cell viability or other cell properties.
Also known as: CardioCell administration
Patients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.
Also known as: Placebo administration
Left ventricle ejection fraction (LVEF) increase
Left ventricle ejection fraction (LVEF) increase, assessed by SPECT at 6M FU vs. during index (baseline) imaging - comparison between two groups (active vs placebo therapy).
Time frame: 6 months FU
An increase the result of 6 minute walk test
An increase the result of 6 minute walk test at 3 and 6 month.
Time frame: 3 and 6 month FU
Myocardial perfusion improvement
Myocardial perfusion improvement assessed in SPECT at 6 month FU.
Time frame: 6 month FU
Myocardial perfusion improvement
Myocardial perfusion improvement assessed in cardiac MRI at 6 month FU.
Time frame: 6 month FU
An improvement the result of spiroergometric test
An improvement the result of spiroergometric test at 6 month FU.
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.
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
NT pro-BNP level
NT pro-BNP level at 3, 6 and 12 months in comparison to the baseline level.
Time frame: 3, 6 and 12 months 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) at 6 month and 1 year FU.
Time frame: 6 month and 1 year FU
Quality of life improvement
Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at 6 month and 1 year FU.
Time frame: 6 month and 1 year FU
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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John Paul II Hospital, Krakow