Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365326
Status:
COMPLETED
Last Update Posted:
2022-03-24
First Post:
2006-08-15
Brief Title:
Safety and Efficacy of Autologous Intracoronary Stem Cell Injections in Total Coronary Artery Occlusions
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
Safety and Efficacy of Autologous Intracoronary Stem Cell Injections in Total Coronary Artery Occlusions
Status:
COMPLETED
Status Verified Date:
2006-08
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:
This phase I clinical trial will evaluate the safety and efficacy of intra-coronary injection of AC133 selected autologous marrow-derived stem cells in patients with chronic coronary artery occlusion A clinical study to determine the therapeutic potential of marrow-derived stem cells as an adjunct therapy to current standard therapies for CAD is warranted The current initiative is to investigate a model of chronic myocardial ischemia and 1 to determine whether intra-coronary injection of selected autologous marrow-derived AC133 stem cells is reasonably safe for use in humans and 2 if this treatment shows any improvement in coronary perfusion as assessed using non-invasive imaging This study is structured to evaluate the feasibility and safety of autologous AC133 bone marrow-derived stem cell via intra-coronary injection into documented ischemic but viable myocardial zones via established collateral vessels The epicardial vessel that normally supplies the ischemic zone must be 100 chronically occluded and considered non-revascularizable by percutaneous means
Detailed Description:
This study is composed of one phase The objective of Phase I is to assess the safety and feasibility of performing escalating doses of autologous AC133 selected bone marrow-derived stem cell with intracoronary infusion via epicardial vessels supplying collateral flow to areas of viable ischemic myocardium in the distribution of a chronic totally occluded vessel Additionally focus on the assessment of the benefit achieved from the infusion of stem cells and subsequent angiogenesis at 6 months will be observed
Potential candidates are patients with a known total occlusion of an epicardial vessel with a documented chronically ischemic territory supplied by collateral conduits
Secondary Objectives include
1 Improvement in ETT as determined by total exercise duration on the 6 month ETT in seconds time to onset of angina one mm ST depression onset of angina or one mm ST depression whichever occurs first
2 Reduction in the area of ischemia will be evaluated by nuclear sestamibi stress imaging with exercise or pharmacologic stress
3 Improvement in viability within the chronically ischemic zone as measured by nuclear sestamibi stress imaging
4 Improvement in angina as per Angina Questionnaire The Seattle Angina Questionnaire at 7 14 30 90 180 and 365 days
5 Major adverse cardiac events MACE assessment composite endpoint including cardiac death myocardial infarction ischemia-driven target vessel revascularization CABG CVA and rehospitalization for angina MACE definitions
Myocardial Infarction All ST segment elevation MIs as diagnosed on electrocardiogram by a staff cardiologist and all non-ST segment elevation MIs as defined by elevation in cardiac enzyme markers per the hospital laboratory guidelines Cerebral Vascular Accidents eg acute neurological event
6 Concomitant Medication usage eg changes in utilization of PRN or sublingual nitroglycerin for angina
7 ECG changes at day of discharge 7 14 30 90 180 and 365 days
8 Functional capacity eg exercise duration time and changes in METS achieved on treadmill study at 6 month follow-up
9 Echocardiogram assessment of left ventricular ejection fraction and regional wall motion abnormalities at 180 days eg changes in regional wall motion score andor changes in left ventricular ejection fraction
Potential candidates are patients with a known total occlusion of an epicardial vessel with a documented chronically ischemic territory supplied by collateral conduits
Secondary Objectives include
1 Improvement in ETT as determined by total exercise duration on the 6 month ETT in seconds time to onset of angina one mm ST depression onset of angina or one mm ST depression whichever occurs first
2 Reduction in the area of ischemia will be evaluated by nuclear sestamibi stress imaging with exercise or pharmacologic stress
3 Improvement in viability within the chronically ischemic zone as measured by nuclear sestamibi stress imaging
4 Improvement in angina as per Angina Questionnaire The Seattle Angina Questionnaire at 7 14 30 90 180 and 365 days
5 Major adverse cardiac events MACE assessment composite endpoint including cardiac death myocardial infarction ischemia-driven target vessel revascularization CABG CVA and rehospitalization for angina MACE definitions
Myocardial Infarction All ST segment elevation MIs as diagnosed on electrocardiogram by a staff cardiologist and all non-ST segment elevation MIs as defined by elevation in cardiac enzyme markers per the hospital laboratory guidelines Cerebral Vascular Accidents eg acute neurological event
6 Concomitant Medication usage eg changes in utilization of PRN or sublingual nitroglycerin for angina
7 ECG changes at day of discharge 7 14 30 90 180 and 365 days
8 Functional capacity eg exercise duration time and changes in METS achieved on treadmill study at 6 month follow-up
9 Echocardiogram assessment of left ventricular ejection fraction and regional wall motion abnormalities at 180 days eg changes in regional wall motion score andor changes in left ventricular ejection fraction
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