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'

Trials. 2011 Feb 7;12:33. doi: 10.1186/1745-6215-12-33.

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).

Discussion: This is the first study to evaluate the safety and efficacy of combination cytokine based progenitor/stem cell treatment.

Trial registration: http://www.ClinicalTrials.gov identifier: NCT00501917.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Combined Modality Therapy
  • Cytokines / therapeutic use
  • Darbepoetin alfa
  • Erythropoietin / analogs & derivatives
  • Erythropoietin / therapeutic use
  • Follow-Up Studies
  • Granulocyte Colony-Stimulating Factor / therapeutic use
  • Hematinics / therapeutic use
  • Hematopoietic Stem Cell Mobilization / adverse effects*
  • Hematopoietic Stem Cell Mobilization / methods*
  • Hematopoietic Stem Cell Transplantation / adverse effects*
  • Hematopoietic Stem Cell Transplantation / methods*
  • Humans
  • Injections
  • Myocardial Infarction / therapy*
  • Prospective Studies
  • Research Design

Substances

  • Cytokines
  • Hematinics
  • Erythropoietin
  • Granulocyte Colony-Stimulating Factor
  • Darbepoetin alfa

Associated data

  • ClinicalTrials.gov/NCT00501917