Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

C-Cure Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810238
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : September 5, 2012
Information provided by (Responsible Party):
Celyad Oncology SA

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.

Condition or disease Intervention/treatment Phase
Heart Failure Class II or III Biological: C-Cure Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 1
Optimal standard of care + C-Cure
Biological: C-Cure
Intraventricular injection

No Intervention: 2
Optimal standard of care

Primary Outcome Measures :
  1. Change in left ventricular ejection fraction [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 6-min walking distance [ Time Frame: 6 months, 1 and 2 years ]
  2. Quality of Life [ Time Frame: 6 months, 1 and 2 years ]
  3. All cause mortality [ Time Frame: Each follow-up ]
  4. Cardiovascular events [ Time Frame: Each follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810238

Layout table for location information
CardioVascular Center
Aalst, Belgium, 9300
Université Catholique de Louvain, Saint-Luc
Brussels, Belgium, 1200
Centre Hospitalier Universitaire
Charleroi, Belgium, 6000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
Virga Jesse Ziekenhuis
Hasselt, Belgium, 3500
Centre Hospitalier Universitaire
Liège, Belgium, 4000
Clinical Center of Serbia
Belgrade, Serbia, 11000
Sponsors and Collaborators
Celyad Oncology SA
Layout table for investigator information
Principal Investigator: Jozef Bartunek, MD, PhD VZW Cardiovascular Research Center Aalst
Principal Investigator: André Terzic, MD, PhD Mayo Clinic, Rochester, USA
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Celyad Oncology SA Identifier: NCT00810238    
Other Study ID Numbers: C3BS-C-07-01
EudraCT 2007-007699-40
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012
Keywords provided by Celyad Oncology SA:
Heart failure
Cell therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases