Stem Cell Therapy in Chronic Ischemic Heart Failure
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|ClinicalTrials.gov Identifier: NCT00235417|
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : June 8, 2007
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Ischemia Heart Failure, Congestive||Procedure: Bone marrow transplantation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2005|
|Actual Study Completion Date :||May 2007|
- Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
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
|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|