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

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ClinicalTrials.gov Identifier: NCT03404063
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
KCRI
National Center for Research and Development, Poland
Information provided by (Responsible Party):
John Paul II Hospital, Krakow

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Cardiac Drug Drug: Placebos Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The Data and Safety Monitoring Board (DSMB) will be blinded at project start, but may request unblinding if necessary to accommodate effective review of data.

Other than the DSMB (if necessary), the only other "un-blinded parties", meaning that they will have knowledge as to the patient's treatment assignment, will be the PBTiK UJ CM employee who participates in randomization utilizing randomization lists and investigational medication preparation.

Primary Purpose: Treatment
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).
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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 Name: 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 Name: Placebo administration




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404063


Contacts
Contact: Piotr Musiałek, MD, PhD +48 12 614 22 87 sekr_kard@szpitaljp2.krakow.pl
Contact: Agnieszka Wilk +48 12 614 25 82 a.wilk@szpitaljp2.krakow.pl

Locations
Poland
The John Paul II Hospital Recruiting
Cracovia, Poland, 31-202
Contact: Piotr Musiałek, MD, PhD    +48 12 614 22 87    sekr_kard@szpitaljp2.krakow.pl   
Contact: Agnieszka Wilk    +48 12 614 25 82    a.wilk@szpitaljp2.krakow.pl   
Principal Investigator: Piotr Musiałek, MD, PhD         
Sponsors and Collaborators
John Paul II Hospital, Krakow
KCRI
National Center for Research and Development, Poland
Investigators
Principal Investigator: Piotr Musiałek, MD, PhD John Paul II Hospital

Responsible Party: John Paul II Hospital, Krakow
ClinicalTrials.gov Identifier: NCT03404063     History of Changes
Other Study ID Numbers: CardioCell evaluation in AMI
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases