NCT00418418

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_2 heart-failure

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 19, 2008

Status Verified

August 1, 2008

Enrollment Period

3.2 years

First QC Date

January 3, 2007

Last Update Submit

August 18, 2008

Conditions

Heart FailureMyocardial InfarctionCoronary Artery Disease

Keywords

Cell transplantationHeart failureClinical trials

Outcome Measures

Primary Outcomes (1)

  • Does a bone marrow transplantation therapy increase the ejection fraction of the heart measured with MRI, when compared with placebo treatment?

    1 year after the transplantation

Secondary Outcomes (5)

  • 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?

    6 months and 1 year after the procedure

  • Does a bone marrow transplantation therapy improve BNP-value?

    3kk, 6 months and 1 year after the procedure

  • Does a bone marrow transplantation therapy decrease hospitalization or the days stayed in hospital?

    primary hospital stay after the transplantation

  • Does pericardial fluid growth factor concentrations correlate to left ventricular function improvement?

    up to 1 year after the translantation

  • Does autologous cardiac stem cell quality correlate to left ventricular function improvement?

    3kk, 6 months and 1 year after the transplantation

Study Arms (2)

A

ACTIVE COMPARATOR

Patient group receiving the stem cell injections during the CABG

Procedure: Coronary bypass operationProcedure: Bone marrow aspiration (crista iliaca)Biological: Intramyocardial mesenchymal stem cell transplantation

B

PLACEBO COMPARATOR

The patient group receiving autologous serum injections during the CAGB operation

Procedure: Coronary bypass operationProcedure: Bone marrow aspiration (crista iliaca)Biological: Intramyocardial injection of autologous serum

Interventions

Coronary bypass operationPROCEDURE

Coronary bypass operation is performed via sternotomy during cardiac arrest.

Also known as: CABG
AB
Bone marrow aspiration (crista iliaca)PROCEDURE

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).

Also known as: Stem cell harvest
AB
Intramyocardial mesenchymal stem cell transplantationBIOLOGICAL

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)

Also known as: Stem cell therapy
A
Intramyocardial injection of autologous serumBIOLOGICAL

Intramyocardial injection of autologous serum is injected during cardiac arrest

Also known as: Stem cell control therapy
B

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery, Meilahti Hospital

Helsinki, 00029-HUS, Finland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25142068DERIVED

  • 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.

    PMID: 24656645DERIVED

MeSH Terms

Conditions

Heart FailureMyocardial InfarctionCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Ari Harjula, MD; PhD

    Department of Cardiothoracic Surgery, Helsinki University MeilahtiHospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari Harjula, MD,PhD

CONTACT

+3585064814ari.harjula@hus.fi

Tommi Pätilä, MD

CONTACT

+358504272291tommi.patila@hus.fi

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

August 19, 2008

Record last verified: 2008-08

Locations

FI(1)