Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Combined CABG and Stem-Cell Transplantation for Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Helsinki University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00418418
First received: January 3, 2007
Last updated: August 18, 2008
Last verified: August 2008

January 3, 2007
August 18, 2008
October 2006
December 2009   (final data collection date for primary outcome measure)
Does a bone marrow transplantation therapy increase the ejection fraction of the heart measured with MRI, when compared with placebo treatment? [ Time Frame: 1 year after the transplantation ] [ Designated as safety issue: Yes ]
Does a bone marrow transplantation therapy increase the ejection fraction of the heart measured with MRI, when compared with placebo treatment?
Complete list of historical versions of study NCT00418418 on ClinicalTrials.gov Archive Site
  • Does a bone marrow transplantation therapy increase any cardiac function parameter measured by a an echocardiography, MRI or PET ischemia area, when compared with no treatment group? [ Time Frame: 6 months and 1 year after the procedure ] [ Designated as safety issue: Yes ]
  • Does a bone marrow transplantation therapy improve BNP-value? [ Time Frame: 3kk, 6 months and 1 year after the procedure ] [ Designated as safety issue: Yes ]
  • Does a bone marrow transplantation therapy decrease hospitalization or the days stayed in hospital? [ Time Frame: primary hospital stay after the transplantation ] [ Designated as safety issue: No ]
  • Does pericardial fluid growth factor concentrations correlate to left ventricular function improvement? [ Time Frame: up to 1 year after the translantation ] [ Designated as safety issue: No ]
  • Does autologous cardiac stem cell quality correlate to left ventricular function improvement? [ Time Frame: 3kk, 6 months and 1 year after the transplantation ] [ Designated as safety issue: No ]
  • Does a bone marrow transplantation therapy increase any cardiac function parameter measured by a an echocardiography, MRI or PET ischemia area, when compared with no treatment group?
  • Does a bone marrow transplantation therapy improve BNP-value?
  • Does a bone marrow transplantation therapy decrease hospitalization or the days stayed in hospital?
  • Does pericardial fluid growth factor concentrations correlate to left ventricular function improvement?
  • Does autologous cardiac stem cell quality correlate to left ventricular function improvement?
  • Does scar area in cardiac late enhancement MR images diminish in the treatmant group?
Not Provided
Not Provided
 
Combined CABG and Stem-Cell Transplantation for Heart Failure
Combined CABG and Stem-Cell Transplantation for Heart Failure

This is a prospective double blind trial of intraoperative transmyocardial bone marrow−derived mesenchymal cell transplantation vs placebo in patients with low left ventricular ejection fraction scheduled to coronary bypass operation.

The prevalence of symptomatic heart failure in general population is up to 2% and the prevalence increases rapidly with age. Half of the patients with symptomatic heart failure will die within 4 years of diagnosis.The purpose of this study is to examine the effect of bone marrow-derived stem cell transplantation in left ventricular ejection fraction.

Consecutive patients with systolic heart failure (n=60), with ischemic coronary heart disease, scheduled to by-pass-operation (CABG) will be collected from cardiovascular laboratory and outpatient clinic of Helsinki University Central Hospital. Patients should have heart failure with ejection fraction between 15 to 45%. Randomly patients are selected to receive a stem cell transplantation with best possible heart failure medication, or without cell transplantation. In this study, 30 patients are receiving bone marrow transplantation, and 30 patients are serving as a control population. All patients will receive CABG.The study will be carried out with randomized, double blind techniques for one year. Randomization (in blocks) will be based on a table of random numbers.Bone marrow and patients own serum will be blinded by using colored syringe, so that the doctor transfusing the sample, will not be able to know the nature of the sample. From all patients, a right atrial biopsy will be collected for assessment of autologous cardiac stem cells. Also sample of pericardial fluid will be collected for measures of growth factors.

Comparisons: Preoperatively, patients will be imagined by cardiac ultrasound, cardiac MRI, cardiac PET and SPECT. Serum pro-BNB samples will be collected. Postoperatively at 3 months and 6 months pro-BNB and cardiac ultrasound will be evaluated. At one year cardiac ultrasound, cardiac MRI, cardiac PET and SPECT will be reassessed.

Heart failure and coronary artery disease treatments beside the transplantation will be optimized according to the judgment of the doctors of the outpatients clinic. Primary endpoint of the study is the change of ejection fraction in MRI images.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Myocardial Infarction
  • Coronary Artery Disease
  • Procedure: Coronary bypass operation
    Coronary bypass operation is performed via sternotomy during cardiac arrest.
    Other Name: CABG
  • Procedure: Bone marrow aspiration (crista iliaca)
    The bone marrow is aspirated from the iliac crest (100ml). During the operation the aspirate is transported to the stem cell laboratory, where the sample is centrifugated through Ficoll(Registered Trademark).
    Other Name: Stem cell harvest
  • Biological: Intramyocardial mesenchymal stem cell transplantation
    During the cardiac arrest, stem cells are directly injected to myocardium. The amount of the cells varies individually (5-1000 x 10e6 cells), the cells are diluted in autologous serum (5 ml)
    Other Name: Stem cell therapy
  • Biological: Intramyocardial injection of autologous serum
    Intramyocardial injection of autologous serum is injected during cardiac arrest
    Other Name: Stem cell control therapy
  • Active Comparator: A
    Patient group receiving the stem cell injections during the CABG
    Interventions:
    • Procedure: Coronary bypass operation
    • Procedure: Bone marrow aspiration (crista iliaca)
    • Biological: Intramyocardial mesenchymal stem cell transplantation
  • Placebo Comparator: B
    The patient group receiving autologous serum injections during the CAGB operation
    Interventions:
    • Procedure: Coronary bypass operation
    • Procedure: Bone marrow aspiration (crista iliaca)
    • Biological: Intramyocardial injection of autologous serum
Pätilä T, Lehtinen M, Vento A, Schildt J, Sinisalo J, Laine M, Hämmäinen P, Nihtinen A, Alitalo R, Nikkinen P, Ahonen A, Holmström M, Lauerma K, Pöyhiä R, Kupari M, Kankuri E, Harjula A. Autologous bone marrow mononuclear cell transplantation in ischemic heart failure: a prospective, controlled, randomized, double-blind study of cell transplantation combined with coronary bypass. J Heart Lung Transplant. 2014 Jun;33(6):567-74. doi: 10.1016/j.healun.2014.02.009. Epub 2014 Feb 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • General (patients must have all)

    • Symptomatic heart failure.
    • Scheduled to CABG
    • Be 18 to 75 years of age
    • Informed Consent obtained
  • Heart Failure Presentation

    • Patients of either gender, who has evaluated in cardiovascular laboratory and scheduled to CABG with moderate heart failure, will be eligible
    • NYHA II-IV symptoms
    • Left ventricular ejection fraction in screening echocardiography 15 to 45%.
    • Optimal heart failure medication and coronary medication before operation, containing at least two heart failure drugs: must have ACE-inhibitor, or AT II blocker, and/or b-blocker together with diuretics, digitalis or aldosterone antagonist, and coronary medication: a statin and anticoagulation, either aspirin or clopidogrel.

Exclusion Criteria:

  • Heart failure due to left ventricular outflow track obstruction (valve problem or HOCM)
  • History of life-threatening ventricular arrhythmias or resuscitation, condition which may be repeatable or implanted ICD.
  • Stroke or other disabling condition with in 3 months before screening
  • Contraindications to coronary angiogram or MRI
  • Other serious disease limiting life expectancy
  • Participation in an other clinical trial
  • Severe valve disease: mitral, aortic, tricuspid or pulmonic stenosis / insufficiency
  • Scheduled valve operation
Both
18 Years to 75 Years
No
Contact: Ari Harjula, MD,PhD +3585064814 ari.harjula@hus.fi
Contact: Tommi Pätilä, MD +358504272291 tommi.patila@hus.fi
Finland
 
NCT00418418
TYH 6220
Yes
Reijo Haapiainen, Helsinki University Hospital
Helsinki University
Not Provided
Principal Investigator: Ari Harjula, MD; PhD Department of Cardiothoracic Surgery, Helsinki University MeilahtiHospital
Helsinki University
August 2008

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