Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289822
Status:
TERMINATED
Last Update Posted:
2006-11-30
First Post:
2006-02-08
Brief Title:
Cell Therapy for Coronary Heart Disease
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None