Ignite Creation Date:
2024-05-06 @ 1:04 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01720888
Status:
UNKNOWN
Last Update Posted:
2015-04-16
First Post:
2012-11-01
Brief Title:
Intracoronary Autologous Mesenchymal Stem Cells Implantation in Patients With Ischemic Dilated Cardiomyopathy
Sponsor:
National University of Malaysia
Organization:
National University of Malaysia
Study Overview
Official Title:
A Controlled Open Label Phase II Study Assessing the Efficacy of Intracoronary Autologous Mesenchymal Stem Cells in Patients With Ischemic Dilated Cardiomyopathy
Status:
UNKNOWN
Status Verified Date:
2015-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Despite the recent advances in medical and surgical treatment heart failure resulting from ischemic cardiomyopathy ICM remains the leading cause of cardiovascular mortality Ischemic dilated cardiomyopathyICM is defined as abnormally enlarged left ventricular LV cavity with documented poor LV function as a result of severe coronary artery disease CAD LV remodelling which is inevitable after an infarct has been postulated to contribute largely to the poor outcome of patients with ICM therefore prevention of LV remodelling is the goal for the treatment in patients with severe CAD Cell therapy represents a novel therapeutic strategy for treating cardiac diseases including severe CAD and heart failure A type of stem cells known as mesenchymal stem cellsMSCscan be isolated from bone marrowThis study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population
Detailed Description:
Ischemic dilated cardiomyopathyICM is defined as abnormally enlarged left ventricular LV cavity with documented poor LV function as a result of severe coronary artery disease CAD LV remodelling which is inevitable after an infarct has been postulated to contribute largely to the poor outcome of patients with ICM therefore prevention of LV remodelling is the goal for the treatment in patients with severe CAD Cell therapy represents a novel therapeutic strategy for treating cardiac diseases including severe CAD and heart failure A type of stem cells known as mesenchymal stem cellsMSCscan be isolated from bone marrow Experimental and clinical studies to date have shown that mesenchymal stem cells represent the most suitable cell type for regeneration therapy after myocardial infarction MI After injection into ischemic myocardium bone marrow-derived MSC BM-MSC from various animal species can differentiate into multiple cell lineages including endothelial cells and cardiomyocytes thereby improving LV function
In Malaysia we have previously demonstrated our capability in isolating and extracting MSC from a small volume of bone marrow aspiratesThe isolation expansion and feasibility of storage transport and differentiation of human MSC for clinical application has been performed locally The researchers used autologous BM-MSC ex vivo expanded on three patients with end-stage ischemic dilated cardiomyopathy who were on the heart transplant waiting list and each patient was injected with MSCs directly into the myocardium during open heart surgery After twelve months all patients remained alive and well with significant improvement in cardiac function quality of life and other parameters including reduction of myocardial scar volume as seen from cardiac scans
The same group of researchers further carried out a study on ten patients with severe dilated cardiomyopathy and refractory cardiac function despite maximum medical therapy to receive autologous BM-MSC implantation via intramyocardial or intracoronary route All patients remained alive at 1 year while recorded significant improvements in LV ejection fraction and other LV parameters from baseline to 6 and 12 months Reduction in scar was also noted in six of the patients by 12 months
Following these results this study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population
In Malaysia we have previously demonstrated our capability in isolating and extracting MSC from a small volume of bone marrow aspiratesThe isolation expansion and feasibility of storage transport and differentiation of human MSC for clinical application has been performed locally The researchers used autologous BM-MSC ex vivo expanded on three patients with end-stage ischemic dilated cardiomyopathy who were on the heart transplant waiting list and each patient was injected with MSCs directly into the myocardium during open heart surgery After twelve months all patients remained alive and well with significant improvement in cardiac function quality of life and other parameters including reduction of myocardial scar volume as seen from cardiac scans
The same group of researchers further carried out a study on ten patients with severe dilated cardiomyopathy and refractory cardiac function despite maximum medical therapy to receive autologous BM-MSC implantation via intramyocardial or intracoronary route All patients remained alive at 1 year while recorded significant improvements in LV ejection fraction and other LV parameters from baseline to 6 and 12 months Reduction in scar was also noted in six of the patients by 12 months
Following these results this study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population
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