Myocardial InfarctionPhase 2/3NCT03404063
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)
A Phase 2/3 study testing Cardiac Drug in people with Myocardial Infarction, run by John Paul II Hospital, Krakow at 2 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Cardiac Drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 2 sitesPoland
- Study dates
- 20 Oct 2017to 31 Mar 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
The John Paul II Hospital
Krakow, 31-202
Central Clinical Hospital of the MSWiA in Warsaw
Warsaw, 02-507
About this study
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).
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.
Read the 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
- Being tested
- Cardiac Drug, Placebos
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac DrugDrug
Also called CardioCell administration
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.
PlacebosDrug
Also called Placebo administration
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | 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. Receives: Drug: Cardiac Drug |
| Control Group | Placebo comparator | 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Index hospitalization and in 6 month FU
Secondary outcomes (10)
Infarct size reduction
Infarct size reduction in SPECT.
Measured: 6 month FU
Myocardial perfusion improvement
Myocardial perfusion improvement assessed in SPECT.
Measured: 6 month FU
Myocardial perfusion improvement
Myocardial perfusion improvement assessed in cardiac MRI.
Measured: 6 month FU
Increase of left ventricle ejection fraction (LVEF)
Increase of left ventricle ejection fraction (LVEF) assessed in cardiac MRI.
Measured: 6 month FU
Increase of left ventricle ejection fraction (LVEF)
Increase of left ventricle ejection fraction (LVEF) assessed in SPECT.
Measured: 6 month FU
Left ventricle ejection fraction (LVEF) change against baseline.
Left ventricle ejection fraction (LVEF) change (in %) against baseline, assessed in echocardiography.
Measured: 6 month FU
Left ventricle end-systolic volume (ESV) change against baseline.
Left ventricle end-systolic volume (ESV, in ml) change against baseline, assessed in echocardiography
Measured: 6 month FU
Left ventricle end-diastolic volume (EDV) change against baseline.
Left ventricle end-diastolic volume (EDV, in ml) change against baseline, assessed in echocardiography.
Measured: 6 month FU
The occurrence of major adverse cardiovascular events
The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure).
Measured: 1 year FU
Quality of life improvement
Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population.
Measured: 6 month and 1 year FU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start20 Oct 2017
- Primary completion2 Jul 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI, National Center for Research and Development, Poland
- Responsible party
- Sponsor
- Investigators
- Piotr Musiałek, MD, PhD, Principal investigator, John Paul II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404063
- Sponsor's protocol ID
- CardioCell evaluation in AMI
- Status last verified
- Apr 2021
- First submitted
- 10 Jan 2018
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03404063
- Acronym / sponsor ID
- CardioCell evaluation in AMI
- Conditions
- Myocardial Infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Collaborators
- KCRI, National Center for Research and Development, Poland
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Drug: Cardiac DrugPatients 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. |
| Control Group | Placebo comparator | Drug: PlacebosPatients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac DrugAlso: CardioCell administrationPatients 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. | Drug | Active Group |
| PlacebosAlso: Placebo administrationPatients 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. | Drug | Control Group |
Primary outcome
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).
10 secondary outcomes
Infarct size reduction
Time frame: 6 month FU
Myocardial perfusion improvement
Time frame: 6 month FU
Myocardial perfusion improvement
Time frame: 6 month FU
Increase of left ventricle ejection fraction (LVEF)
Time frame: 6 month FU
Increase of left ventricle ejection fraction (LVEF)
Time frame: 6 month FU
Left ventricle ejection fraction (LVEF) change against baseline.
Time frame: 6 month FU
Left ventricle end-systolic volume (ESV) change against baseline.
Time frame: 6 month FU
Left ventricle end-diastolic volume (EDV) change against baseline.
Time frame: 6 month FU
The occurrence of major adverse cardiovascular events
Time frame: 1 year FU
Quality of life improvement
Time frame: 6 month and 1 year FU.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Musiałek, MD, PhD principal investigator
John Paul II Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cardiac Drug in people with Myocardial Infarction, run by John Paul II Hospital, Krakow at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of infarct size (time frame: Index hospitalization and in 6 month FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.