The purpose of this study is to determine the safety of injecting autologous bone marrow concentrate with laser transmyocardial revascularization (TMR) for treatment of angina which cannot be treated by direct coronary intervention.
Recently published information suggests the delivery of concentrated autologous bone marrow, in combination with transmyocardial revascularization (TMR) may provide synergistic effects for the reduction of angina in patients who are not treatable with conventional coronary artery bypass or percutaneous coronary intervention. This safety and feasibility study is intended to confirm the work previously done at one hospital in a larger, multicenter setting. Patients who are candidates for TMR will be asked to participate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Injection of up to 18 mL BMAC
Bakoulev Scientific Center for Cardio-vascular Surgery
Moscow, Russia
Hospital Universitario de La Princesa
Madrid, Spain
Major adverse cardiac and cerebral events (MACCE)
MACCE is defined as cardiac death, cerebrovascular accidents, myocardial infarction, serious arrhythmia and congestive heart failure
Time frame: One Year
Mortality
All cause mortality
Time frame: One Year
Exercise Tolerance Test
Exercise tolerance to onset of moderately severe angina
Time frame: 3, 6 and 12 months
Ejection Fraction
Ejection fraction and areas of myocardial ischemia by cardiac MRI
Time frame: 6 and 12 months
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