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

NCT ID: NCT03404063

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• 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 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.

Conditions

Myocardial Infarction

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 will receive 30 000 000 WJMSCs suspended in 20mL 0.9% NaCl and 5% albumin administered via the IRA.

Group Type: EXPERIMENTAL

Cardiac Drug

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

CardioCell administration; Placebo administration

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

• 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

The John Paul II Hospital

Krakow, , Poland

Central Clinical Hospital of the MSWiA in Warsaw

Warsaw, , Poland

Countries

Poland

Other Identifiers

CardioCell evaluation in AMI

Identifier Type: -

Identifier Source: org_study_id