AMI: Acute Myocardial Infarction MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: CardioCell
Product Name: CardioCell
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intraar
Sponsors
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Acute myocardial infarction successfully treated by infarct related artery (IRA) successful revascularization - Male and female patients, aged 18-80 years - Large myocardial injury as demonstrated by LVEF =45% and/or infarct size (IS) =10% of the LV muscle on cMRI 2-5 days after pPCI - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115
Exclusion criteria
Exclusion criteria: - Pacemaker or other contraindications to cardiac MRI - Malignancy - Moderate or severe immunodeficiency - Acute or chronic bacterial or viral infectious disease - Soft tissue disease or local infection in a place of required artery puncture - Pregnancy or breastfeeding - Any objective or subjective reason for inability to attend follow-up visits - Females of childbearing potential, who does not want to use a highly effective method of contraception - Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test - Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this project - Life expectancy < 1 year - Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine. Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’. Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with acute myocardial infarction (AMI).;Secondary Objective: Assess the effectiveness of the use of the product on the basis of reduction in size of the area of ischemia assessed in Cardiac MRI at baseline and at follow-up at 6 months between the two groups (active vs sham).;Primary end point(s): 1. Reduction of infarct size assessed in cardiac MRI during index hospitalization and in 6M FU between two groups (active vs placebo therapy).;Timepoint(s) of evaluation of this end point: 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3, 6 and 12 months;Secondary end point(s): 1. Infarct size reduction in SPECT at 6 month FU. 2. Myocardial perfusion improvement assessed in SPECT at 6 month FU. 3. Myocardial perfusion improvement assessed in cardiac MRI at 6 month FU. 4. Left ventricle ejection fraction (LVEF) increase assessed in cardiac MRI at 6 month FU. 5. Left ventricle ejection fraction (LVEF) increase assessed in SPECT at 6 month FU. 6. Left ventricle ejection fraction (LVEF), end-systolic volume (ESV) and end-diastolic volume (EDV) change against baseline, assessed in echocardiography at 6 month FU. 7. The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure) at 1 year FU. 8. Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at 6 month and 1 year FU. | — |
Countries
Poland
Contacts
Public ContactClinical Trial Information Desk
Ewa Gasior
Outcome results
None listed