title: Safety and feasibility of combined granulocyte colony stimulating factor and erythropoetin based-stem cell therapy using intracoronary infusion of peripheral blood stem cells in patients with recent anterior myocardial infarction: one-year follow-up of a phase 1 study.
abstract: OBJECTIVE
  to assess the safety and feasibility of combined granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) based intracoronary peripheral blood stem cells (PBSCs) therapy in patients with recent myocardial infarction (RMI) who had successful reperfusion therapy with drug-eluting stent.
  
  
  METHODS
  a total of 18 patients diagnosed with anterior ST-segment elevation AMI who had successful percutaneous coronary intervention (PCI) with drug-eluting stent implantation within 15 days after onset of symptom were enrolled. PBSCs were harvested and injected into the infarct-related artery after 5 consecutive days of G-CSF administration. Recombinant human erythropoietin was administered at the time of intracoronary PBSCs injection.
  
  
  RESULTS
  there were no procedural and periprocedural complications, such as ventricular arrhythmia, visible thrombus formation, distal embolization, injury of the coronary artery associated with the cell infusion catheterization procedure or elevation of CK-MB of more than two-times. After PBSCs injection, all patients had grade III myocardial blush grade. At follow-up of 21.1±5.5 months (range 12 to 30 months) there was no death, no re-infarction, no target lesion revascularization nor re-hospitalization for heart failure. Paired cardiac MRI demonstrated no change in left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) at 3 months, but they increased significantly at one year. Despite this, left ventricular ejection fraction (LVEF), wall motion score index (WMSI) and perfusion score index (PSI) improved at 3 months and remained stable at one year. The percentage of late gadolinium enhancement to LV mass (%LGE) were continuously improved until one year. There was no correlation between the level of CD34+, CD 45+, other cell subtypes as well as total number of PBSCs injected to the changes of LVEDV, LVESV, LVEF, WMSI, PSI, and %LGE (p >0.05).
  
  
  CONCLUSIONS
  combined G-CSF and EPO based- intracoronary infusion of PBSCs in patients RAMI is safe and feasible.
authors.affiliation: Department of Internal Medicine, University of Indonesia, Faculty of Medicine-Dr. Cipto Mangunkusumo Hospital. Jl. Diponegoro no. 71, Jakarta, Indonesia. tsantoso@cbn.net.id
authors.forename: Teguh
authors.initials: T
authors.lastname: Santoso
authors.forename: Cosphiadi
authors.initials: C
authors.lastname: Irawan
authors.forename: Idrus
authors.initials: I
authors.lastname: Alwi
authors.forename: Auda
authors.initials: A
authors.lastname: Aziz
authors.forename: Agus
authors.initials: A
authors.lastname: Kosasih
authors.forename: Sri
authors.initials: S
authors.lastname: Inggriani
authors.forename: Ardian
authors.initials: A
authors.lastname: Saputra
authors.forename: Merry
authors.initials: M
authors.lastname: Wintery
authors.forename: Linda
authors.initials: L
authors.lastname: Lison
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D054855:Drug-Eluting Stents; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D013318:Stroke Volume; D013997:Time Factors; D016277:Ventricular Function, Left
chemical_list: D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor