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
  Purpose

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 Intervention Phase
Heart Failure Class II or III
Biological: C-Cure
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Cardio3 BioSciences:

Primary Outcome Measures:
  • Change in left ventricular ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: December 2008
Study Completion Date: January 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Optimal standard of care + C-Cure
Biological: C-Cure
Intraventricular injection
No Intervention: 2
Optimal standard of care

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810238

Locations
Belgium
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
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Sponsors and Collaborators
Cardio3 BioSciences
Investigators
Principal Investigator: Jozef Bartunek, MD, PhD Cardiovascular Center Aalst, Belgium
Principal Investigator: André Terzic, MD, PhD Mayo Clinic, Rochester, USA
  More Information

No publications provided by Cardio3 BioSciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cardio3 BioSciences
ClinicalTrials.gov Identifier: NCT00810238     History of Changes
Other Study ID Numbers: C3BS-C-07-01, EudraCT 2007-007699-40
Study First Received: December 17, 2008
Last Updated: September 3, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cardio3 BioSciences:
Heart failure
Cell therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 15, 2014