title: A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'.
abstract: BACKGROUND
  Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function. However, the improvement of left ventricular systolic function is limited. This study will evaluate novel stem/progenitor cell therapy with combination cytokine treatment of the long-acting erythropoietin analogue, darbepoetin, and granulocyte colony-stimulating factor (G-CSF) in patients with acute myocardial infarction.
  
  
  METHODS
  The 'MAGIC Cell-5-Combination Cytokine Trial' is a multicenter, prospective, randomized, 3-arm, controlled trial with blind evaluation of the endpoints. A total of 116 patients will randomly receive one of the following three treatments: an intravenous darbepoetin infusion and intracoronary infusion of peripheral blood stem cells mobilized with G-CSF (n = 58), an intracoronary infusion of peripheral blood stem cells mobilized with G-CSF alone (n = 29), or conventional therapy (n = 29) at phase I. Patients with left ventricular ejection fraction < 45% at 6 months, in the patients who received stem cell therapy at phase I, will receive repeated cell therapy at phase II. The objectives of this study are to evaluate the safety and efficacy of combination cytokine therapy with erythropoietin and G-CSF (phase I) and repeated progenitor/stem cell treatment (phase II).
  
  
  CONCLUSIONS
  This is the first study to evaluate the safety and efficacy of combination cytokine based progenitor/stem cell treatment.
  
  
  BACKGROUND
  http://www.ClinicalTrials.gov identifier: NCT00501917.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 28 Yongon-dong, Jongno-gu, Seoul, Korea.
authors.forename: Hyun-Jae
authors.initials: HJ
authors.lastname: Kang
authors.forename: Min-Kyung
authors.initials: MK
authors.lastname: Kim
authors.forename: Myung-Gon
authors.initials: MG
authors.lastname: Kim
authors.forename: Dong-Ju
authors.initials: DJ
authors.lastname: Choi
authors.forename: Jung-Han
authors.initials: JH
authors.lastname: Yoon
authors.forename: Young-Bae
authors.initials: YB
authors.lastname: Park
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D003131:Combined Modality Therapy; D016207:Cytokines / Q000627:therapeutic use; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000031:analogs & derivatives / Q000627:therapeutic use; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006397:Hematinics / Q000627:therapeutic use; D019650:Hematopoietic Stem Cell Mobilization / Q000009:adverse effects* / Q000379:methods*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects* / Q000379:methods*; D006801:Humans; D007267:Injections; D009203:Myocardial Infarction / Q000628:therapy*; D011446:Prospective Studies; D012107:Research Design
chemical_list: D016207:Cytokines; D006397:Hematinics; D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor; D000068256:Darbepoetin alfa