Combined CABG and Stem-Cell Transplantation for Heart Failure

August 18, 2008 updated by: University of Helsinki
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

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

  • Finland
      • Helsinki, Finland, 00029-HUS
        • Recruiting
        • Department of Cardiothoracic Surgery, Meilahti Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ari Harjula, MD, PhD
        • Principal Investigator:
          • Tommi Pätilä, MD
        • Principal Investigator:
          • Sinisalo Juha, MD, PhD
        • Principal Investigator:
          • Antti Vento, MD,PhD
        • Sub-Investigator:
          • Mika Laine, MD,PhD
        • Sub-Investigator:
          • Pekka Hämmäinen, MD, PhD
        • Sub-Investigator:
          • Esko Kankuri, MD, PhD
        • Sub-Investigator:
          • Reino Pöyhiä, MD, PhD
        • Sub-Investigator:
          • Raili Suojaranta-Ylinen, MD, PhD
        • Sub-Investigator:
          • Aapo Ahonen, MD, PhD
        • Sub-Investigator:
          • Jorma Sipponen, MD, PhD
        • Sub-Investigator:
          • Markku Kupari, MD, PhD
        • Sub-Investigator:
          • Riitta Alitalo, MD; PhD

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:

  • 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

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: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Patient group receiving the stem cell injections during the CABG
Procedure: Coronary bypass operation
Coronary bypass operation is performed via sternotomy during cardiac arrest.
Other Names:
  • 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 Names:
  • 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 Names:
  • Stem cell therapy
Placebo Comparator: B
The patient group receiving autologous serum injections during the CAGB operation
Procedure: Coronary bypass operation
Coronary bypass operation is performed via sternotomy during cardiac arrest.
Other Names:
  • 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 Names:
  • Stem cell harvest
Biological: Intramyocardial injection of autologous serum
Intramyocardial injection of autologous serum is injected during cardiac arrest
Other Names:
  • Stem cell control therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year after the transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months and 1 year after the procedure
Does a bone marrow transplantation therapy improve BNP-value?
Time Frame: 3kk, 6 months and 1 year after the procedure
3kk, 6 months and 1 year after the procedure
Does a bone marrow transplantation therapy decrease hospitalization or the days stayed in hospital?
Time Frame: primary hospital stay after the transplantation
primary hospital stay after the transplantation
Does pericardial fluid growth factor concentrations correlate to left ventricular function improvement?
Time Frame: up to 1 year after the translantation
up to 1 year after the translantation
Does autologous cardiac stem cell quality correlate to left ventricular function improvement?
Time Frame: 3kk, 6 months and 1 year after the transplantation
3kk, 6 months and 1 year after the transplantation

Collaborators and Investigators

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

Sponsor

University of Helsinki

Investigators

  • Principal Investigator: Ari Harjula, MD; PhD, Department of Cardiothoracic Surgery, Helsinki University MeilahtiHospital

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

October 1, 2006

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

August 19, 2008

Last Update Submitted That Met QC Criteria

August 18, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYH 6220

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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