Clinical trial NCT03404063: Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)
Official title: Regeneration of Ischemic Damages in Cardiovascular System Using Wharton's Jelly as an Unlimited Source of Mesenchymal Stem Cells for Regenerative Medicine. Project of the National Centre for Research and Development (Poland) 'STRATEGMED II'. Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Myocardial Infarction
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
Collaborators: name: KCRI
name: National Center for Research and Development, Poland
First posted: 2018-01-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The AMI trial will enroll 105 patients with randomization into active vs. sham 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 uptake and retention of IMP in the target ischemic tissues.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of infarct size
timeFrame: Index hospitalization and in 6 month FU
Secondary outcomes:
measure: Infarct size reduction
timeFrame: 6 month FU
measure: Myocardial perfusion improvement
timeFrame: 6 month FU
measure: Myocardial perfusion improvement
timeFrame: 6 month FU
measure: Increase of left ventricle ejection fraction (LVEF)
timeFrame: 6 month FU
measure: Increase of left ventricle ejection fraction (LVEF)
timeFrame: 6 month FU
measure: Left ventricle ejection fraction (LVEF) change against baseline.
timeFrame: 6 month FU
measure: Left ventricle end-systolic volume (ESV) change against baseline.
timeFrame: 6 month FU
measure: Left ventricle end-diastolic volume (EDV) change against baseline.
timeFrame: 6 month FU
measure: The occurrence of major adverse cardiovascular events
timeFrame: 1 year FU
measure: Quality of life improvement
timeFrame: 6 month and 1 year FU.
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: The John Paul II Hospital
city: Warsaw
country: Poland
facility: Central Clinical Hospital of the MSWiA in Warsaw
Study officials:
affiliation: John Paul II Hospital
name: Piotr Musiałek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: