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

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Paul II Hospital, Krakow
• Collaborators: KCRI; National Center for Research and Development, Poland

Criteria

Inclusion Criteria:

• Patients aged 18-80 years

• Diagnosis of ischemic heart failure (supported by history of CAD or revascularization by PCI or CABG procedure) without known need for revascularization or feasibility of revascularization

• Substantial chronic ischemic myocardial injury as demonstrated by LVEF ≤45% by SPECT and 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 their territories (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 or other 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 of contraception

• Females of childbearing potential in absence of 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 < 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, would make the patient unsuitable for participation in the project