Treatment of ischemic myocardium has been the subject of intense research in recent years and stem cell therapy is one of the great promises. The InCor laboratory has studied cells from different backgrounds as candidates for cell therapy in the context of myocardial infarction. Evidence in preclinical studies of the application of stromal (mesenchymal) adipose tissue (hASC) in the ischemic heart by both the InCor group (in the animal model in rodents and pigs) and others in the literature suggest relevant benefits on the decrease of deterioration post-infarction. More recently it has been demonstrated that it arises mainly from the formation of new vessels due to paracrine factors, which are secreted by the injected cells. There are currently no studies in Brazil in which the safety of injecting different doses of hASC cells into the heart has been particularly evaluated. Recently, two studies have demonstrated the clinical applicability of hASC in patients with peripheral ischemic disease and stroke. Thus, the objective of this work will be to test the hypothesis that the implantation of autologous stromal cells derived from adipose tissue combined with myocardial revascularization surgery in patients with coronary artery disease
To test the hypothesis that the implantation of adipose-derived autologous cells derived from adipose tissue (hASCs) combined with coronary artery bypass grafting in patients with coronary artery disease is safe and well tolerated, besides being able to promote regional perfusion increase in the injected segments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Adipose stromal cell
Cardiovascular Death
Death due to stroke, myocardial infarction or other cardiovascular causes
Time frame: 12 months
Unstable angina
Occurence of angina requiring hospitalization
Time frame: 12 months
Acute myocardial infarction
Occurence of acute myocardial infarction (with or without ST segment elevation)
Time frame: 12 months after procedure
Unplanned myocardial revascularization surgery
Need for urgent surgical myocardial revascularization
Time frame: 12 months
Unplanned myocardial revascularization through angioplasty
Need for urgent non-surgical myocardial revascularization
Time frame: 12 months
All cause mortality
Time frame: 12 months
Stroke
Time frame: 12 months
Cardiogenic shock
Time frame: 12 months
Occurence of complex ventricular arrhythmia
Time frame: 12 months
New onset atrial fibrilation
Time frame: 12 months
Occurence of acute pulmonary edema
Time frame: 12 months
Pulmonary embolism
Time frame: 12 months
Acute respiratory failure of any cause
Time frame: 12 months
Septic shock
Disseminated infection requiring vasopressors
Time frame: 12 months
New onset cancer
Diagnosis of any cancer at any stage during study period
Time frame: 12 month
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