C-Cure Clinical Trial

Heart Failure Class II or III Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810238
• Other study ID #: C3BS-C-07-01
• Secondary ID: EudraCT 2007-007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 17, 2008
• Last updated: September 3, 2012
• Start date: December 2008
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Celyad (formerly named Cardio3 BioSciences)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Class II or III

Intervention

Biological:
• C-Cure
Intraventricular injection

Locations

Country	Name	City	State
Belgium	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
Serbia	Clinical Center of Serbia	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Celyad (formerly named Cardio3 BioSciences)

Countries where clinical trial is conducted

Belgium,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular ejection fraction		6 months	No
Secondary	6-min walking distance		6 months, 1 and 2 years	No
Secondary	Quality of Life		6 months, 1 and 2 years	No
Secondary	All cause mortality		Each follow-up	Yes
Secondary	Cardiovascular events		Each follow-up	Yes