Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221182
Status:
TERMINATED
Last Update Posted:
2011-06-22
First Post:
2005-09-13
Brief Title:
Stem Cell Study for Patients With Heart Disease
Sponsor:
Foundation for Biomedical Research and Innovation
Organization:
Foundation for Biomedical Research and Innovation
Study Overview
Official Title:
Phase I II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells CD34 Cells in No-Option Patients With Chronic Myocardial Ischemia
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment of the study subjects
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 if stem cell therapy with your own cells autologous cells delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain increase the blood flow andor improve the cardiac contractility function by regenerating blood vessels in your heart
Detailed Description:
Chronic myocardial ischemia MI is a progressive disease which arises as a result of atherosclerosis in coronary arteries Prognosis of chronic MI is poor and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the coronary arteries or frequent reocclusion following revascularization Therefore it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells CD34 positive cells in patients with severe chronic coronary artery disease CAD who are not eligible for traditional revascularization treatments The primary endpoint is the severity of myocardial ischemia identified by sestamibi SPECT stress myocardial scintigraphy and the evaluation of adverse effect rates while the secondary endpoints are evaluation of CCSAS and NYHA classification regional myocardial blood flow as revealed by PET scan and various left ventricular function indices
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