Combined CABG and Stem-Cell Transplantation for Heart Failure
NCT ID: NCT00418418
Last Updated: 2008-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2006-10-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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A
Patient group receiving the stem cell injections during the CABG
Coronary bypass operation
Coronary bypass operation is performed via sternotomy during cardiac arrest.
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).
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)
B
The patient group receiving autologous serum injections during the CAGB operation
Coronary bypass operation
Coronary bypass operation is performed via sternotomy during cardiac arrest.
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).
Intramyocardial injection of autologous serum
Intramyocardial injection of autologous serum is injected during cardiac arrest
Interventions
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Coronary bypass operation
Coronary bypass operation is performed via sternotomy during cardiac arrest.
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).
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)
Intramyocardial injection of autologous serum
Intramyocardial injection of autologous serum is injected during cardiac arrest
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
Responsible Party
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Helsinki University Hospital
Principal Investigators
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Ari Harjula, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiothoracic Surgery, Helsinki University MeilahtiHospital
Locations
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Department of Cardiothoracic Surgery, Meilahti Hospital
Helsinki, , Finland
Countries
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Central Contacts
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Facility Contacts
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Ari Harjula, MD, PhD
Role: primary
Tommi Pätilä, MD, PhD
Role: backup
References
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Lehtinen M, Patila T, Vento A, Kankuri E, Suojaranta-Ylinen R, Poyhia R, Harjula A; Helsinki BMMC Collaboration. Prospective, randomized, double-blinded trial of bone marrow cell transplantation combined with coronary surgery - perioperative safety study. Interact Cardiovasc Thorac Surg. 2014 Dec;19(6):990-6. doi: 10.1093/icvts/ivu265. Epub 2014 Aug 20.
Patila T, Lehtinen M, Vento A, Schildt J, Sinisalo J, Laine M, Hammainen P, Nihtinen A, Alitalo R, Nikkinen P, Ahonen A, Holmstrom M, Lauerma K, Poyhia 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.
Other Identifiers
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TYH 6220
Identifier Type: -
Identifier Source: org_study_id