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Stem Cell Therapy in Chronic Ischemic Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00235417
First received: October 6, 2005
Last updated: June 7, 2007
Last verified: June 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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:

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

No publications provided by Odense University Hospital

Additional 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
Study First Received: October 6, 2005
Last Updated: June 7, 2007
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Bone Marrow Transplantation

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

ClinicalTrials.gov processed this record on May 19, 2013