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

Myocardial Infarction Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404063
• Other study ID #: CardioCell evaluation in AMI
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 20, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: John Paul II Hospital, Krakow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 31, 2021
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	The John Paul II Hospital	Cracovia
Poland	Central Clinical Hospital of the MSWiA in Warsaw	Warsaw

Sponsors (3)

Lead Sponsor	Collaborator
John Paul II Hospital, Krakow	KCRI, National Center for Research and Development, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Infarct size reduction	Infarct size reduction in SPECT.	6 month FU
Secondary	Myocardial perfusion improvement	Myocardial perfusion improvement assessed in SPECT.	6 month FU
Secondary	Myocardial perfusion improvement	Myocardial perfusion improvement assessed in cardiac MRI.	6 month FU
Secondary	Increase of left ventricle ejection fraction (LVEF)	Increase of left ventricle ejection fraction (LVEF) assessed in cardiac MRI.	6 month FU
Secondary	Increase of left ventricle ejection fraction (LVEF)	Increase of left ventricle ejection fraction (LVEF) assessed in SPECT.	6 month FU
Secondary	Left ventricle ejection fraction (LVEF) change against baseline.	Left ventricle ejection fraction (LVEF) change (in %) against baseline, assessed in echocardiography.	6 month FU
Secondary	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
Secondary	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
Secondary	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
Secondary	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.