Cell Therapy for Coronary Heart Disease
|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.|
|ClinicalTrials.gov Identifier: NCT00289822|
Recruitment Status : Terminated
First Posted : February 10, 2006
Last Update Posted : November 30, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: intracoronary infusion of progenitor cells||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||75 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2002|
|Study Completion Date :||January 2005|
- 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
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): NCT00289822
|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|