NCT00810238

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2008

Typical duration for phase_2

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

1.6 years

First QC Date

December 17, 2008

Last Update Submit

September 3, 2012

Conditions

Heart Failure Class II or III

Keywords

Heart failureCell therapy

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricular ejection fraction

    6 months

Secondary Outcomes (4)

  • 6-min walking distance

    6 months, 1 and 2 years

  • Quality of Life

    6 months, 1 and 2 years

  • All cause mortality

    Each follow-up

  • Cardiovascular events

    Each follow-up

Study Arms (2)

1

EXPERIMENTAL

Optimal standard of care + C-Cure

Biological: C-Cure

2

NO INTERVENTION

Optimal standard of care

Interventions

C-CureBIOLOGICAL

Intraventricular injection

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CardioVascular Center

Aalst, 9300, Belgium

Location

Université Catholique de Louvain, Saint-Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier Universitaire

Charleroi, 6000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Virga Jesse Ziekenhuis

Hasselt, 3500, Belgium

Location

Centre Hospitalier Universitaire

Liège, 4000, Belgium

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Related Publications (1)

  • 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.

    PMID: 23583246DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jozef Bartunek, MD, PhD

    VZW Cardiovascular Research Center Aalst

    PRINCIPAL INVESTIGATOR

  • André Terzic, MD, PhD

    Mayo Clinic, Rochester, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2010

Study Completion

January 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

BE(7)SE(1)