Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235417
Status:
COMPLETED
Last Update Posted:
2007-06-08
First Post:
2005-10-06
Brief Title:
Stem Cell Therapy in Chronic Ischemic Heart Failure
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-06
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:
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
Detailed Description:
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
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 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