C-Cure Clinical Trial

NCT ID: NCT00810238

Last Updated: 2012-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-01-31

Brief 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.

Conditions

Heart Failure Class II or III

Keywords

Heart failure; Cell therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Optimal standard of care + C-Cure

Group Type: EXPERIMENTAL

C-Cure

Intervention Type: BIOLOGICAL

Intraventricular injection

2

Optimal standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

C-Cure

Intraventricular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celyad Oncology SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jozef Bartunek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VZW Cardiovascular Research Center Aalst

André Terzic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic, Rochester, USA

Locations

CardioVascular Center

Aalst, , Belgium

Université Catholique de Louvain, Saint-Luc

Brussels, , Belgium

Centre Hospitalier Universitaire

Charleroi, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Ziekenhuis Oost Limburg

Genk, , Belgium

Virga Jesse Ziekenhuis

Hasselt, , Belgium

Centre Hospitalier Universitaire

Liège, , Belgium

Clinical Center of Serbia

Belgrade, , Serbia

Countries

Belgium; Serbia

References

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.

Reference Type: DERIVED

PMID: 23583246 (View on PubMed)

Other Identifiers

EudraCT 2007-007699-40

Identifier Type: -

Identifier Source: secondary_id

C3BS-C-07-01

Identifier Type: -

Identifier Source: org_study_id