C-Cure Clinical Trial

September 3, 2012 updated by: Celyad Oncology SA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Cardiovascular Center
      • Brussels, Belgium, 1200
        • Université Catholique de Louvain, Saint-Luc
      • Charleroi, Belgium, 6000
        • Centre Hospitalier Universitaire
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Genk, Belgium, 3600
        • Ziekenhuis Oost Limburg
      • Hasselt, Belgium, 3500
        • Virga Jesse Ziekenhuis
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Optimal standard of care + C-Cure
Biological: C-Cure
Intraventricular injection
No Intervention: 2
Optimal standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in left ventricular ejection fraction
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
6-min walking distance
Time Frame: 6 months, 1 and 2 years
6 months, 1 and 2 years
Quality of Life
Time Frame: 6 months, 1 and 2 years
6 months, 1 and 2 years
All cause mortality
Time Frame: Each follow-up
Each follow-up
Cardiovascular events
Time Frame: Each follow-up
Each follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celyad Oncology SA

Investigators

  • Principal Investigator: Jozef Bartunek, MD, PhD, VZW Cardiovascular Research Center Aalst
  • Principal Investigator: André Terzic, MD, PhD, Mayo Clinic, Rochester, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 3, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3BS-C-07-01
  • EudraCT 2007-007699-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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