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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Cardiac Drug
Placebos
Sponsored by
John Paul II Hospital, Krakow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The John Paul II Hospital
  • Central Clinical Hospital of the MSWiA in Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2018
Last Updated
April 8, 2021
Sponsor
John Paul II Hospital, Krakow
Collaborators
KCRI, National Center for Research and Development, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT03404063
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
John Paul II Hospital, Krakow
Collaborators
KCRI, National Center for Research and Development, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cardiac Drug
Other Intervention Name(s)
CardioCell administration
Intervention Description
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
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo administration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of infarct size
Description
Reduction of infarct size assessed in cardiac MRI during index hospitalization and in 6 month FU between two groups (active vs sham).
Time Frame
Index hospitalization and in 6 month FU
Secondary Outcome Measure Information:
Title
Infarct size reduction
Description
Infarct size reduction in SPECT.
Time Frame
6 month FU
Title
Myocardial perfusion improvement
Description
Myocardial perfusion improvement assessed in SPECT.
Time Frame
6 month FU
Title
Myocardial perfusion improvement
Description
Myocardial perfusion improvement assessed in cardiac MRI.
Time Frame
6 month FU
Title
Increase of left ventricle ejection fraction (LVEF)
Description
Increase of left ventricle ejection fraction (LVEF) assessed in cardiac MRI.
Time Frame
6 month FU
Title
Increase of left ventricle ejection fraction (LVEF)
Description
Increase of left ventricle ejection fraction (LVEF) assessed in SPECT.
Time Frame
6 month FU
Title
Left ventricle ejection fraction (LVEF) change against baseline.
Description
Left ventricle ejection fraction (LVEF) change (in %) against baseline, assessed in echocardiography.
Time Frame
6 month FU
Title
Left ventricle end-systolic volume (ESV) change against baseline.
Description
Left ventricle end-systolic volume (ESV, in ml) change against baseline, assessed in echocardiography
Time Frame
6 month FU
Title
Left ventricle end-diastolic volume (EDV) change against baseline.
Description
Left ventricle end-diastolic volume (EDV, in ml) change against baseline, assessed in echocardiography.
Time Frame
6 month FU
Title
The occurrence of major adverse cardiovascular events
Description
The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure).
Time Frame
1 year FU
Title
Quality of life improvement
Description
Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population.
Time Frame
6 month and 1 year FU.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Musiałek, MD, PhD
Organizational Affiliation
John Paul II Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The John Paul II Hospital
City
Cracovia
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Central Clinical Hospital of the MSWiA in Warsaw
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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