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

Last updated: April 8, 2021
Sponsor: John Paul II Hospital, Krakow
Overall Status: Completed

Phase

2/3

Condition

Circulation Disorders

Cardiovascular Disease

Heart Defect

Treatment

N/A

Clinical Study ID

NCT03404063
CardioCell evaluation in AMI
  • Ages 18-80
  • All Genders

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

Eligibility Criteria

Inclusion

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% ofthe LV muscle on cMRI 2-5 days after pPCI
  • Signed informed consent

Exclusion

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 methodof contraception
  • Females of childbearing potential who does not have a menstrual period confirmed and anegative highly sensitive urine or serum 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 < 1 year
  • Any concurrent disease or condition that, in the opinion of the investigator, wouldmake the patient unsuitable for participation in the project

Study Design

Total Participants: 105
Study Start date:
October 20, 2017
Estimated Completion Date:
March 31, 2021

Study 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.

Connect with a study center

  • The John Paul II Hospital

    Cracovia, 31-202
    Poland

    Site Not Available

  • Central Clinical Hospital of the MSWiA in Warsaw

    Warsaw, 02-507
    Poland

    Site Not Available

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