Stem Cell Therapy in Chronic Ischemic Heart Failure
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).
Heart Failure, Congestive
Procedure: Bone marrow transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
|Study Start Date:||October 2005|
|Study Completion Date:||May 2007|
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.
|Department of Cardiology, Odense University Hospital|
|Odense, Odense C, Denmark, DK-5000|
|Study Director:||Per Thayssen, MDSci||Department of Cardiology, Odense University Hospital|
|Principal Investigator:||Axel CP Diederichsen, phd||Department of Cardiology, Odense University Hospital|