Safety and Efficacy of Autologous, Intracoronary Stem Cell Injections in Total Coronary Artery Occlusions
| Status: | Archived |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
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.
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 (e.g., acute neurological event).
6. Concomitant Medication usage (e.g., 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 (e.g., 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 (e.g., changes in regional wall motion score and/or
changes in left ventricular ejection fraction).
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