Fig. 1
Study design and assessment timeline. Clinical trial visits are structured in 9 time-points, that include two pre-infusion visits (screening and randomization), BMMNC/placebo infusion day, and 6 post-infusion follow-up evaluation time-points according to a decreasing frequency: 24 h, 3 months, 6 months, 12 months, 18 months and 24 months. The procedures and evaluations performed are detailed for each visit. Biochemical determinations: glucose, urea, creatinine, sodium, potassium, C reactive protein (CRP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), bilirubin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, lactate dehydrogenase (LDH). Cardiac enzymes: Creatine kinase (CK), Troponin I or US and brain natriuretic peptide (BNP) or N-terminal fragment of pro-brain natriuretic peptide (NT-proBNP). Demographic data: date of born, sex. Echocardiogram (Echo): Left ventricular (LV) ejection fraction (LVEF, %), LV end-diastolic volume (LVEDV, ml), LV end-systolic volume (LVESV, ml), LV end-diastolic diameter (LVED, mm), LV end-systolic diameter (LVSD, mm), left atrial (LA) area (cm2), right ventricular (RV) end-diastolic volume (RVEDV, ml), Tricuspid annular plane systolic excursion (TAPSE, mm). Electrocardiogram (ECG): synusal rhythm, conduction disturbances, atrial fibrillation (AF), right bundle branch block (RBBB), left bundle branch block (LBBB), left anterior hemiblock (LAHB), QRS duration (sec), PR duration (sec), heart rate (bpm). Exercise testing (ExTest) (according to Naughton protocol): Metabolic equivalents (METS), exercise time (min). Hemogram: red blood cell (RBC) count, hemoglobin, hematocrit, white blood cell (WBC) count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), erythrocyte sedimentation rate (ESR), platelets. Medical history: personal antecedents, cardiovascular risk factors (hypertension, dyslipidemia, tobacco and alcohol consumption, history of ischemic cardiomyopathy). Clinical evaluation: adverse events (AEs), concomitant drugs and procedures evaluation. Serology: human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV). Tumoral markers: CA125, CA19.9, carcinoembryonic antigen (CEA), and alpha-fetoprotein (AFP), Beta-hCG (BHCG), prostate-specific antigen (PSA). Ventriculography: LVEF in sinus rhythm (%), LVEF in sinus rhythm post-PVC (premature ventricular contraction) (%), Sinus end-diastolic volume (mL/m2), Sinus end-systolic volume (mL/m2), Post-PVC end-diastolic volume (mL/m2), Post-PVC end-systolic volume (mL/m2), hypokinesia in sinus rhythm, hypokinesia post-PVC, acute coronary syndrome (ACS) in sinus rhythm, ACS post-PVC, left ventricular end-diastolic pressure and heart rate (bpm). Vital signs: blood pressure (mmHg), heart rate (bpm)