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Heart FailurePhase 2/3NCT03418233

Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)

A Phase 2/3 study testing CardioCell in people with Heart Failure, run by John Paul II Hospital, Krakow at 5 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 receive the placebo. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
CardioCell
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
115 participants
Where
5 sitesPoland
Study dates
19 Apr 2018to 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

  • Patients aged 18-80 years
  • Diagnosis of ischemic heart failure (supported by history of CAD or revascularization by PCI or CABG procedure) without known need for revascularization or feasibility of revascularization
  • Substantial chronic ischemic myocardial injury as demonstrated by LVEF ≤45% by SPECT and the clinical stage of NYHA II or III
  • At least 50% viable myocardium (SPECT)
  • Patency of at least two major coronary arteries and/or bypass grafts supplying their territories (confirmed in angiography within 12 months)
  • Clinically stable CIHF for at least 3 months on guideline recommended therapy
  • Signed informed consent

Who cannot join

  • Other than ischemic cause of cardiomyopathy
  • Less than 3 months from any substantial therapeutic intervention (such as, e.g. CRT/ICD fitting or revascularization)
  • Less than 3 months from ACS
  • BMI lower than 18 or greater than 45kg/m2
  • Severe valvular heart disease or left ventricle aneurysm requiring aneurysmectomy or other structural interventions
  • Candidate for heart transplantation
Show all 21Show fewer
  • Active or any history of malignancy or tumor
  • Moderate or severe immunodeficiency
  • Chronic immunosuppressive therapy
  • Acute or chronic infection
  • Coagulopathies
  • Known alcohol or drug dependence
  • Severe renal dysfunction (eGFR<20mL/min)
  • Soft tissue disease or local infection in a place of required artery puncture
  • Pregnancy or breastfeeding
  • Females of childbearing potential who do not use a highly effective method of contraception
  • Females of childbearing potential in absence of 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 < 12 months
  • Any objective or subjective reason for inability to attend follow-up visits
  • 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

5 sites in 1 country.

5 sites in 1 country

Poland5 sites

  • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

    Katowice, 04-628

  • Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice

    Katowice, 40-635

  • The John Paul II Hospital

    Krakow, 31-202

  • The University Hospital in Cracow

    Krakow, 31-501

  • Central Clinical Hospital of the MSWiA in Warsaw

    Warsaw, 02-507

Other trials in Poland

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'. Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)

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 receive the placebo.

Read the detailed description

The CIHF trial will enroll 105 patients with randomization into active and placebo 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 myocardial uptake and retention of IMP.

The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with CIHF. There are several secondary questions, defined by secondary endpoints in each cohort, e.g.: if the investigated treatment is possible to administered, if the investigated treatment and way of CardioCell administration is safe, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.

Conditions
Heart Failure
Being tested
CardioCell, Placebos
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioCellDrug

    Also called CardioCell administration

    Patients randomized to the active treatment group will receive transcoronary or trans-bypass graft administration of 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin).

    Injection will be performed using a dedicated cell delivery catheter. The cell delivery catheter is a typical coronary balloon catheter that is CE marked (1.2x10 mm balloon, RX system) modified to include cell delivery perforations in the balloon section of the catheter. The cell delivery catheter has been demonstrated not to affect cell viability or other cell properties.

  • PlacebosDrug

    Also called Placebo administration

    Patients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.

Study groups in NCT03418233
Study groupRoleWhat they receive
Active GroupActive comparatorPatients randomized to the active treatment group: Transcoronary or trans-bypass graft administration of CardioCell consist 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin) will be performed using a dedicated cell delivery catheter. The cell delivery catheter is a typical coronary balloon catheter that is CE marked (1.2x10 mm balloon, RX system) modified to include cell delivery perforations in the balloon section of the catheter. The cell delivery catheter has been demonstrated not to affect cell viability or other cell properties.
Receives: Drug: CardioCell
Control GroupPlacebo comparatorPatients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricle ejection fraction (LVEF) increase

    Left ventricle ejection fraction (LVEF) increase, assessed by SPECT at 6M FU vs. during index (baseline) imaging - comparison between two groups (active vs placebo therapy).

    Measured: 6 months FU

Secondary outcomes (10)

  1. An increase the result of 6 minute walk test

    An increase the result of 6 minute walk test at 3 and 6 month.

    Measured: 3 and 6 month FU

  2. Myocardial perfusion improvement

    Myocardial perfusion improvement assessed in SPECT at 6 month FU.

    Measured: 6 month FU

  3. Myocardial perfusion improvement

    Myocardial perfusion improvement assessed in cardiac MRI at 6 month FU.

    Measured: 6 month FU

  4. An improvement the result of spiroergometric test

    An improvement the result of spiroergometric test at 6 month FU.

    Measured: 6 month FU

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

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

    Measured: 6 month FU

  6. 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

  7. 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

  8. NT pro-BNP level

    NT pro-BNP level at 3, 6 and 12 months in comparison to the baseline level.

    Measured: 3, 6 and 12 months FU

  9. The occurrence of major adverse cardiovascular events

    The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure) at 6 month and 1 year FU.

    Measured: 6 month and 1 year FU

  10. Quality of life improvement

    Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at 6 month and 1 year FU.

    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.

  1. First posted1 Feb 2018
  2. Study start19 Apr 2018
  3. Primary completion27 Jan 2021
  4. Study completion31 Mar 2021

Resources

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 CIHF trial will enroll 105 patients with randomization into active and placebo 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 myocardial uptake and retention of IMP.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03418233
Sponsor's protocol ID
CardioCell in CIHF
Status last verified
Apr 2021
First submitted
25 Jan 2018
Last updated
9 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CardioCell in people with Heart Failure, run by John Paul II Hospital, Krakow at 5 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 7 inclusion and 21 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 5 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?

Left ventricle ejection fraction (LVEF) increase (time frame: 6 months FU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03418233.

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.

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