Cell Therapy for Coronary Heart Disease
Impaired contractile function after a heart attack and due to coronary heart disease is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy.
The aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (>= 3 months) myocardial infarction.
Coronary Artery Disease
Drug: intracoronary infusion of progenitor cells
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cell Therapy for Coronary Heart Disease: Infusion of Autologous Ex Vivo Cultivated Endothelial Progenitor Cells (EPCs)” and Autologous Bone Marrow Progenitor Cells in Crossover Design for Improvement of Vascularization and Cardiac Function|
- Change in global left ventricular function (measured by quantitative left ventricular angiography)
- Quantitative parameters of regional left ventricular function of the target area
- changes in left ventricular volumes
- functional status as assessed by NYHA classification
- event-free survival after 4 months follow-up
|Study Start Date:||January 2002|
|Estimated Study Completion Date:||January 2005|
- The study is an open-label, controlled, randomized single-center trial.
- Patients post myocardial infarction (>= 3 months) with a patent infarct-related artery are included.
- Bone marrow-derived progenitor cells are aspirated under local anaesthesia, and after cell processing, are infused into the patent infarct-related artery during stop flow within the same day. Blood-derived progenitor cells are isolated out of 250ml peripheral venous blood, and after cell processing and 3 days culture, are infused into the patent infarct-related artery during stop flow. In addition, left ventricular angiography is performed. In the control group coronary angiography and left ventricular angiography without any intracoronary infusion are performed.
- After 3 months, left ventricular angiography is repeated, and patients of the control group cross-over to active treatment with progenitor cells, whereas patients initially treated with progenitor cells cross-over to the alternate cell type.
- The primary endpoint is the change in quantitative global left ventricular ejection fraction in LV angiography between the groups.
|J. W. Goethe University Hospitals|
|Frankfurt, Germany, 60590|
|Principal Investigator:||Andreas M Zeiher, MD||J. W. Goethe University Hospitals|
|Study Director:||Volker Schaechinger, MD||J. W. Goethe University Hospitals|