Stem Cell Therapy in Chronic Ischemic Heart Failure - Full Text View

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00235417

Purpose

The purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs).

Condition	Intervention	Phase
Myocardial Ischemia Heart Failure, Congestive	Procedure: Bone marrow transplantation	Phase II

MedlinePlus related topics: Bone Marrow Transplantation Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Changes in left ventricular ejection fraction from baseline to 12 months' follow-up

Estimated Enrollment:	35
Study Start Date:	October 2005
Study Completion Date:	May 2007

Detailed Description:

Despite standard therapies (revascularization and drugs), patients with severe ischemic heart failure have a high morbidity and mortality.

The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure.

35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Severe ischemic heart failure and no other other option for standard therapies (revascularization and drugs),
Stable left ventricular ejection fraction < 40%,
CCS class 2-3 and/or NYHA class 2-3, and
Signed informed consent.

Exclusion Criteria:

Implantation of pacemaker (including implantable cardioverter defibrillator [ICD] and biventricular pacing),
Acute myocardial infarction within 3 months,
Atrial fibrillation, or
Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235417

Locations

Denmark, Odense C
Department of Cardiology, Odense University Hospital
Odense, Odense C, Denmark, DK-5000

Sponsors and Collaborators

Odense University Hospital

Investigators

Study Director:	Per Thayssen, MDSci	Department of Cardiology, Odense University Hospital
Principal Investigator:	Axel CP Diederichsen, phd	Department of Cardiology, Odense University Hospital

More Information

Study ID Numbers:	Stem cell
Study First Received:	October 6, 2005
Last Updated:	June 7, 2007
ClinicalTrials.gov Identifier:	NCT00235417
Health Authority:	Denmark: National Board of Health

Keywords provided by Odense University Hospital:

Bone Marrow Transplantation

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009