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

NCT ID: NCT03418233

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2021-03-31

Brief 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.

Detailed Description

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Group

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.

Group Type: ACTIVE_COMPARATOR

CardioCell

Intervention Type: DRUG

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.

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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.

Interventions

CardioCell

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.

Intervention Type: DRUG

Placebos

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.

Intervention Type: DRUG

Other Intervention Names

CardioCell administration; Placebo administration

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCRI

OTHER

Sponsor Role: collaborator

National Center for Research and Development, Poland

OTHER

Sponsor Role: collaborator

John Paul II Hospital, Krakow

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Musiałek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

John Paul II Hospital

Locations

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

Katowice, , Poland

Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice

Katowice, , Poland

The John Paul II Hospital

Krakow, , Poland

The University Hospital in Cracow

Krakow, , Poland

Central Clinical Hospital of the MSWiA in Warsaw

Warsaw, , Poland

Countries

Poland

Other Identifiers

CardioCell in CIHF

Identifier Type: -

Identifier Source: org_study_id