Status:
COMPLETED
C-Cure Clinical Trial
Lead Sponsor:
Celyad Oncology SA
Conditions:
Heart Failure Class II or III
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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 setti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00810238
Start Date
December 1 2008
End Date
January 1 2012
Last Update
September 5 2012
Active Locations (8)
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1
CardioVascular Center
Aalst, Belgium, 9300
2
Université Catholique de Louvain, Saint-Luc
Brussels, Belgium, 1200
3
Centre Hospitalier Universitaire
Charleroi, Belgium, 6000
4
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650