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

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).

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Cardiac Drug; Drug: Placebos

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Poland
  • Cracovia, Poland, 31-202
    • The John Paul II Hospital
  • Warsaw, Poland, 02-507
    • Central Clinical Hospital of the MSWiA in Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Group; 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.	Drug: Cardiac Drug; Patients in the AMI trial will receive one dose of IMP during the index procedure. The IMP administration will be performed by dedicated catheter into infarct related artery. Active IMP consist of 30 000 000 of Wharton's jelly mesenchymal stem cells (WJMSCs) in each IMP dose prepared for patients randomized into active treatment group.; Other Names: CardioCell administration
Placebo Comparator: Control Group; 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.	Drug: Placebos; 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. Control group will receive the same amount of fluid used for WJMSCs preparation, without cells.; Other Names: Placebo administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of infarct size	Reduction of infarct size assessed in cardiac MRI during index hospitalization and in 6 month FU between two groups (active vs sham).	Index hospitalization and in 6 month FU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct size reduction	Infarct size reduction in SPECT.	6 month FU
Myocardial perfusion improvement	Myocardial perfusion improvement assessed in SPECT.	6 month FU
Myocardial perfusion improvement	Myocardial perfusion improvement assessed in cardiac MRI.	6 month FU
Increase of left ventricle ejection fraction (LVEF)	Increase of left ventricle ejection fraction (LVEF) assessed in cardiac MRI.	6 month FU
Increase of left ventricle ejection fraction (LVEF)	Increase of left ventricle ejection fraction (LVEF) assessed in SPECT.	6 month FU
Left ventricle ejection fraction (LVEF) change against baseline.	Left ventricle ejection fraction (LVEF) change (in %) against baseline, assessed in echocardiography.	6 month FU
Left ventricle end-systolic volume (ESV) change against baseline.	Left ventricle end-systolic volume (ESV, in ml) change against baseline, assessed in echocardiography	6 month FU
Left ventricle end-diastolic volume (EDV) change against baseline.	Left ventricle end-diastolic volume (EDV, in ml) change against baseline, assessed in echocardiography.	6 month FU
The occurrence of major adverse cardiovascular events	The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure).	1 year FU
Quality of life improvement	Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population.	6 month and 1 year FU.

Collaborators and Investigators

• Sponsor: John Paul II Hospital, Krakow
• Collaborators: National Center for Research and Development, Poland; KCRI
• Investigators: Principal Investigator: Piotr Musiałek, MD, PhD, John Paul II Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): July 2, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: CardioCell evaluation in AMI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No