Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)

Inclusion Criteria:

• Patients aged 18-80 years
• Diagnosis of ischemic heart failure (supported by history of CAD or revascularizationby PCI or CABG procedure) without known need for revascularization or feasibility ofrevascularization
• Substantial chronic ischemic myocardial injury as demonstrated by LVEF ≤45% by SPECTand the clinical stage of NYHA II or III
• At least 50% viable myocardium (SPECT)
• Patency of at least two major coronary arteries and/or bypass grafts supplying theirterritories (confirmed in angiography within 12 months)
• Clinically stable CIHF for at least 3 months on guideline recommended therapy
• Signed informed consent

Exclusion Criteria:

• Other than ischemic cause of cardiomyopathy
• Less than 3 months from any substantial therapeutic intervention (such as, e.g.CRT/ICD fitting or revascularization)
• Less than 3 months from ACS
• BMI lower than 18 or greater than 45kg/m2
• Severe valvular heart disease or left ventricle aneurysm requiring aneurysmectomy orother structural interventions
• Candidate for heart transplantation
• Active or any history of malignancy or tumor
• Moderate or severe immunodeficiency
• Chronic immunosuppressive therapy
• Acute or chronic infection
• Coagulopathies
• Known alcohol or drug dependence
• Severe renal dysfunction (eGFR<20mL/min)
• Soft tissue disease or local infection in a place of required artery puncture
• Pregnancy or breastfeeding
• Females of childbearing potential who do not use a highly effective method ofcontraception
• Females of childbearing potential in absence of a negative highly sensitive urine orserum pregnancy test
• Participation in any other clinical research study that has not reached the primaryefficacy endpoint or otherwise would interfere with the patient's participation inthis project
• Life expectancy < 12 months
• Any objective or subjective reason for inability to attend follow-up visits
• Any concurrent disease or condition that, in the opinion of the investigator, wouldmake the patient unsuitable for participation in the project