Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)

John Paul II Hospital, Krakow

Status and phase: Completed; Phase 3; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: Placebos; Drug: Cardiac Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT03404063

CardioCell evaluation in AMI

Details and patient eligibility

About

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 be treated by the administration of placebo during the sham procedure.

Full description

It is planned to enroll 105 patients into AMI trial with randomization into active (CardioCell) therapy and sham procedure/placebo administration 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 uptake and retention of IMP in the target ischemic tissues.

The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with AMI. There are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe and way of CardioCell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 2 patient groups, including a placebo group

Active Group

Experimental group

Description:

Patients randomized to the active treatment group will receive 30 000 000 WJMSCs suspended in 20mL 0.9% NaCl and 5% albumin administered via the IRA.

Treatment:

Drug: Cardiac Drug

Control Group

Placebo Comparator group

Description:

Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner.

Treatment:

Drug: Placebos