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Stem Cell Therapy in Chronic Ischemic Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235417
First Posted: October 10, 2005
Last Update Posted: June 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Odense University Hospital
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Implantation of pacemaker (including implantable cardioverter defibrillator [ICD] and biventricular pacing),
  2. Acute myocardial infarction within 3 months,
  3. Atrial fibrillation, or
  4. Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235417


Locations
Denmark
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00235417     History of Changes
Other Study ID Numbers: Stem cell
First Submitted: October 6, 2005
First Posted: October 10, 2005
Last Update Posted: June 8, 2007
Last Verified: June 2007

Keywords provided by Odense University Hospital:
Bone Marrow Transplantation

Additional relevant MeSH terms:
Heart Failure
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases