Clinical profile of patients enroled in a cell therapy trial for severe coronary artery disease

Aims and objectives. To compare the clinical profile of patients included in a clinical trial of autologous bone marrow cells as an adjunctive therapy to coronary artery bypass grafting with that of patients undergoing routine coronary artery bypass grafting. Background. The therapeutic potential of autologous bone marrow cells has been explored in the treatment of severe coronary artery disease. There are few data regarding the clinical and socio‐economic profile of patients included in clinical trials using bone marrow cell. Design. Case–control study. Method. Sixty‐seven patients (61 SD 9) years, 82% men) with multivessel coronary artery disease were divided into two groups: patients in the bone marrow cell group (n = 34) underwent incomplete coronary artery bypass grafting + intramyocardial injection of autologous bone marrow cells (lymphomonocytic fraction −2·0 (SD 0·2 × 108) cells/patient) in the ischaemic, non‐revascularised myocardium, whereas patients in the coronary artery bypass grafting group (n = 33) underwent routine bypass surgery. Demographics, socio‐economic status, clinical and echocardiographic data were collected. Statistical analysis included the Fisher’s exact test (categorical variables) and the Student’s t‐test (continuous variables). Results. There were no significant differences between groups regarding age, gender, BMI, heart rate, blood pressure and echo data. There was a greater prevalence of obesity (65 vs. 33%; OR = 3·7 [1·3–10·1]), of previous myocardial infarction (68 vs. 39%; OR = 3·2 [1·2–8·8]) and prior revascularisation procedures (59 vs. 24%; OR = 4·5 [1·6–12·7]) in the autologous bone marrow cells group and of smokers in the coronary artery bypass grafting group (51 vs. 23%; OR = 3·5 [1·2–10·4]). Conclusions. Patients included in this clinical trial of autologous bone marrow cells for severe coronary artery disease presented a greater prevalence of myocardial revascularisation procedures, indicating a more severe clinical presentation of the disease. Fewer smokers in this group could be attributable to life style changes after previous cardiovascular events and/or interventions. Relevance to clinical practice. The knowledge of the clinical profile of patients included in cell therapy trials may help researchers in the identification of patients that may be enroled in future clinical trials of this new therapeutic strategy.