C-Cure Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cardio3 BioSciences
ClinicalTrials.gov Identifier:
NCT00810238
First received: December 17, 2008
Last updated: September 3, 2012
Last verified: September 2012

December 17, 2008
September 3, 2012
December 2008
July 2010   (final data collection date for primary outcome measure)
Change in left ventricular ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810238 on ClinicalTrials.gov Archive Site
  • 6-min walking distance [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Each follow-up ] [ Designated as safety issue: Yes ]
  • Cardiovascular events [ Time Frame: Each follow-up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
C-Cure Clinical Trial
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure Class II or III
Biological: C-Cure
Intraventricular injection
  • Experimental: 1
    Optimal standard of care + C-Cure
    Intervention: Biological: C-Cure
  • No Intervention: 2
    Optimal standard of care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
January 2012
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Serbia
 
NCT00810238
C3BS-C-07-01, EudraCT 2007-007699-40
Yes
Cardio3 BioSciences
Cardio3 BioSciences
Not Provided
Principal Investigator: Jozef Bartunek, MD, PhD Cardiovascular Center Aalst, Belgium
Principal Investigator: André Terzic, MD, PhD Mayo Clinic, Rochester, USA
Cardio3 BioSciences
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP