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NCT Number: NCT03404063

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The John Paul II Hospital, Krakow, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Drug

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

Placebos

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.

Other names: Placebo administration

Primary outcomes

  1. Reduction of infarct size

    Time frame: Index hospitalization and in 6 month FU

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

Secondary outcomes

  1. Infarct size reduction

    Time frame: 6 month FU

    Infarct size reduction in SPECT.

  2. Myocardial perfusion improvement

    Time frame: 6 month FU

    Myocardial perfusion improvement assessed in SPECT.

  3. Myocardial perfusion improvement

    Time frame: 6 month FU

    Myocardial perfusion improvement assessed in cardiac MRI.

  4. Increase of left ventricle ejection fraction (LVEF)

    Time frame: 6 month FU

    Increase of left ventricle ejection fraction (LVEF) assessed in cardiac MRI.

  5. Increase of left ventricle ejection fraction (LVEF)

    Time frame: 6 month FU

    Increase of left ventricle ejection fraction (LVEF) assessed in SPECT.

  6. Left ventricle ejection fraction (LVEF) change against baseline.

    Time frame: 6 month FU

    Left ventricle ejection fraction (LVEF) change (in %) against baseline, assessed in echocardiography.

  7. Left ventricle end-systolic volume (ESV) change against baseline.

    Time frame: 6 month FU

    Left ventricle end-systolic volume (ESV, in ml) change against baseline, assessed in echocardiography

  8. Left ventricle end-diastolic volume (EDV) change against baseline.

    Time frame: 6 month FU

    Left ventricle end-diastolic volume (EDV, in ml) change against baseline, assessed in echocardiography.

  9. The occurrence of major adverse cardiovascular events

    Time frame: 1 year FU

    The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure).

  10. Quality of life improvement

    Time frame: 6 month and 1 year FU.

    Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population.

Sponsors and collaborators

Lead sponsor

John Paul II Hospital, Krakow

Other

Collaborators

  • KCRI
  • National Center for Research and Development, Poland

Registry information

Official study 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).

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jan 19, 2018
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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