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'

Hyun Jae Kang, Min Kyung Kim, Myung Gon Kim, Dong Ju Choi, Junghan Yoon, Young Bae Park, Hyo Soo Kim

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Article number33
JournalTrials
Volume12
DOIs
Publication statusPublished - 2011 Feb 7

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Granulocyte Colony-Stimulating Factor
Stem Cells
Randomized Controlled Trials
Myocardial Infarction
Cytokines
Safety
Cell- and Tissue-Based Therapy
Erythropoietin
Left Ventricular Function
Therapeutics
Stem Cell Transplantation
Intravenous Infusions
Stroke Volume
Bone Marrow

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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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).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.",
author = "Kang, {Hyun Jae} and Kim, {Min Kyung} and Kim, {Myung Gon} and Choi, {Dong Ju} and Junghan Yoon and Park, {Young Bae} and Kim, {Hyo Soo}",
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T1 - 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

T2 - Study design and rationale of the 'MAGIC cell-5-combination cytokine trial'

AU - Kang, Hyun Jae

AU - Kim, Min Kyung

AU - Kim, Myung Gon

AU - Choi, Dong Ju

AU - Yoon, Junghan

AU - Park, Young Bae

AU - Kim, Hyo Soo

PY - 2011/2/7

Y1 - 2011/2/7

N2 - 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.

AB - 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.

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