Heart Failure Class II or IIIPhase 2/3NCT00810238
C-Cure Clinical Trial
A Phase 2/3 study testing C-Cure in people with Heart Failure Class II or III, run by Celyad Oncology SA at 8 sites in 2 countries.
Trial summary
The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure Class II or III
- What is being tested?
- C-Cure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2008to Jan 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 and < 75 years old;
- Subject has Heart Failure, New York Heart Association (NYHA) class II or class III with LVEF > 15% and ≤ 40% as assessed by transthoracic echocardiography;
- Subject has ischemic heart disease;
- Subject has an identifiable (by transthoracic echocardiography) area of transmural scar within the left ventricle;
- Subject is on optimal and stable medical therapy for more than 2 months;
- Subject is willing and able to undergo an ICD implantation, prior to receiving C-Cure™ or already has an ICD implanted;
- Subject agrees to comply with all follow-up evaluations;
- Subject has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent.
Who cannot join
- Subject has been treated with cell-based therapy;
- Subject has myocardial revascularization by PCI or CABG within 2 months prior to enrolment;
- Subject has had an MI within 2 months prior to enrolment;
- Subject is planned for PCI, CABG or any cardiac surgery;
- Subject has received a biventricular pacemaker within 6 month prior to enrolment;
- Subject has moderate to severe aortic valve heart disease, aortic or mitral prosthetic valve;
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- Subject has a significant mitral valve insufficiency (Effective Regurgitant Orifice (ERO) > 0.2 cm²) with possibility of mitral valve surgery;
- Subject has left ventricular thrombus;
- Subject has LV aneurysma or is a candidate for surgical aneurysmectomy;
- Subject LV ventricular wall thickness is < 5 mm in the target territory;
- Subject has proven high grade atrioventricular block or sustained ventricular tachyarrhythmias;
- Subject has an hemodynamically significant congenital heart disorder;
- Subject has clinical evidence for infection or active malignancy;
- Subject has known stable chronic kidney dysfunction with serum creatinine > 2.5 mg/dL at two occasions during the screening period;
- Subject has experienced severe adverse reaction/allergies to contrast agents;
- Subject has atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree, that could impede or preclude the safe retrograde passage of the delivery catheter, in the judgment of the investigator;
- Subject is on chronic immunosuppressive transplant therapy;
- Subject had an autologous or allogenic bone marrow or peripheral stem cell transplant or prior solid organ transplantation;
- Subject has a multisystem disease;
- Subject has been tested positive for Human Immunodeficiency Virus (HIV 1 or HIV 2), Hepatitis B Virus (HBV), Hepatitis C (HCV) and/or syphilis;
- Women of child bearing potential;
- Subject has life expectancy < 1 year from non heart failure related causes;
- Subject suffers from morbid obesity (Body Mass Index (BMI) > 40);
- Subject has a recent history of alcohol or drug abuse;
- Subject has any other surgical or medical condition that, in the judgment of the investigator might warrant exclusion or be contraindicated for safety reasons;
- Subject is currently participating in another trial.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Belgium7 sites
CardioVascular Center
Aalst, 9300
Université Catholique de Louvain, Saint-Luc
Brussels, 1200
Centre Hospitalier Universitaire
Charleroi, 6000
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Ziekenhuis Oost Limburg
Genk, 3600
Virga Jesse Ziekenhuis
Hasselt, 3500
Centre Hospitalier Universitaire
Liège, 4000
About this study
Official title: C-Cure - Safety, Feasibility and Efficacy of Guided Bone Marrow-derived Mesenchymal Cardiopoietic Cells for the Treatment of Heart Failure Secondary to Ischemic Cardiomyopathy
The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.
- Conditions
- Heart Failure Class II or III
- Being tested
- C-Cure
- Keywords
- Heart failure, Cell therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CureBiological
Intraventricular injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Optimal standard of care + C-Cure Receives: Biological: C-Cure |
| 2 | No intervention | Optimal standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular ejection fraction
Measured: 6 months
Secondary outcomes (4)
6-min walking distance
Measured: 6 months, 1 and 2 years
Quality of Life
Measured: 6 months, 1 and 2 years
All cause mortality
Measured: Each follow-up
Cardiovascular events
Measured: Each follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure Class II or IIIStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celyad Oncology SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jozef Bartunek, MD, PhD, Principal investigator, VZW Cardiovascular Research Center AalstAndré Terzic, MD, PhD, Principal investigator, Mayo Clinic, Rochester, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810238
- Sponsor's protocol ID
- C3BS-C-07-01
- Other IDs
- EudraCT 2007-007699-40
- Status last verified
- Sep 2012
- First submitted
- 17 Dec 2008
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bartunek J, Behfar A, Dolatabadi D, Vanderheyden M, Ostojic M, Dens J, El Nakadi B, Banovic M, Beleslin B, Vrolix M, Legrand V, Vrints C, Vanoverschelde JL, Crespo-Diaz R, Homsy C, Tendera M, Waldman S, Wijns W, Terzic A. Cardiopoietic stem cell therapy in heart failure: the C-CURE (Cardiopoietic stem Cell therapy in heart failURE) multicenter randomized trial with lineage-specified biologics. J Am Coll Cardiol. 2013 Jun 11;61(23):2329-38. doi: 10.1016/j.jacc.2013.02.071. Epub 2013 Apr 10.
PubMed 23583246
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-Cure - Safety, Feasibility and Efficacy of Guided Bone Marrow-derived Mesenchymal Cardiopoietic Cells for the Treatment of Heart Failure Secondary to Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00810238
- Acronym / sponsor ID
- C3BS-C-07-01
- Conditions
- Heart Failure Class II or III
- Keywords
- Heart failure, Cell therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Celyad Oncology SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Dec 2008 (estimated)
- 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 purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: C-CureOptimal standard of care + C-Cure |
| 2 | No intervention | –Optimal standard of care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is ≥ 18 and < 75 years old;
- Subject has Heart Failure, New York Heart Association (NYHA) class II or class III with LVEF > 15% and ≤ 40% as assessed by transthoracic echocardiography;
- Subject has ischemic heart disease;
- Subject has an identifiable (by transthoracic echocardiography) area of transmural scar within the left ventricle;
- Subject is on optimal and stable medical therapy for more than 2 months;
Key exclusion criteria (26 listed)
- Subject has been treated with cell-based therapy;
- Subject has myocardial revascularization by PCI or CABG within 2 months prior to enrolment;
- Subject has had an MI within 2 months prior to enrolment;
- Subject is planned for PCI, CABG or any cardiac surgery;
- Subject has received a biventricular pacemaker within 6 month prior to enrolment;
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 |
|---|---|---|
| C-CureIntraventricular injection | Biological | 1 |
Primary outcome
Change in left ventricular ejection fraction
Time frame: 6 months
4 secondary outcomes
6-min walking distance
Time frame: 6 months, 1 and 2 years
Quality of Life
Time frame: 6 months, 1 and 2 years
All cause mortality
Time frame: Each follow-up
Cardiovascular events
Time frame: Each follow-up
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 5 Sep 2012.
- Derived from this study: PubMed 23583246Bartunek J, Behfar A, Dolatabadi D, Vanderheyden M, Ostojic M, Dens J, El Nakadi B, Banovic M, Beleslin B, Vrolix M, Legrand V, Vrints C, Vanoverschelde JL, Crespo-Diaz R, Homsy C, Tendera M, Waldman S, Wijns W, Terzic A. Cardiopoietic stem cell therapy in heart failure: the C-CURE (Cardiopoietic stem Cell therapy in heart failURE) multicenter randomized trial with lineage-specified biologics. J Am Coll Cardiol. 2013 Jun 11;61(23):2329-38. doi: 10.1016/j.jacc.2013.02.071. Epub 2013 Apr 10.
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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.
Jozef Bartunek, MD, PhD principal investigator
VZW Cardiovascular Research Center Aalst
André Terzic, MD, PhD principal investigator
Mayo Clinic, Rochester, USA
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing C-Cure in people with Heart Failure Class II or III, run by Celyad Oncology SA at 8 sites in 2 countries.
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 8 inclusion and 26 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 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Serbia. 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. 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?
Change in left ventricular ejection fraction (time frame: 6 months). 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 NCT00810238, which also lists 1 linked publication.
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 5 Sep 2012.