Cargando…
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'
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 cel...
Autores principales: | , , , , , , |
---|---|
Formato: | Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2011
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3045901/ https://www.ncbi.nlm.nih.gov/pubmed/21299845 http://dx.doi.org/10.1186/1745-6215-12-33 |
_version_ | 1782198880975192064 |
---|---|
author | Kang, Hyun-Jae Kim, Min-Kyung Kim, Myung-Gon Choi, Dong-Ju Yoon, Jung-Han Park, Young-Bae Kim, Hyo-Soo |
author_facet | Kang, Hyun-Jae Kim, Min-Kyung Kim, Myung-Gon Choi, Dong-Ju Yoon, Jung-Han Park, Young-Bae Kim, Hyo-Soo |
author_sort | Kang, Hyun-Jae |
collection | PubMed |
description | 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. |
format | Text |
id | pubmed-3045901 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-30459012011-03-01 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' Kang, Hyun-Jae Kim, Min-Kyung Kim, Myung-Gon Choi, Dong-Ju Yoon, Jung-Han Park, Young-Bae Kim, Hyo-Soo Trials Study Protocol 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. BioMed Central 2011-02-07 /pmc/articles/PMC3045901/ /pubmed/21299845 http://dx.doi.org/10.1186/1745-6215-12-33 Text en Copyright ©2011 Kang et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Kang, Hyun-Jae Kim, Min-Kyung Kim, Myung-Gon Choi, Dong-Ju Yoon, Jung-Han Park, Young-Bae Kim, Hyo-Soo 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' |
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' |
title_full | 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' |
title_fullStr | 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' |
title_full_unstemmed | 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' |
title_short | 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' |
title_sort | 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' |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3045901/ https://www.ncbi.nlm.nih.gov/pubmed/21299845 http://dx.doi.org/10.1186/1745-6215-12-33 |
work_keys_str_mv | AT kanghyunjae amulticenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetr AT kimminkyung amulticenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetr AT kimmyunggon amulticenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetr AT choidongju amulticenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetr AT yoonjunghan amulticenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetr AT parkyoungbae amulticenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetr AT kimhyosoo amulticenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetr AT kanghyunjae multicenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetri AT kimminkyung multicenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetri AT kimmyunggon multicenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetri AT choidongju multicenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetri AT yoonjunghan multicenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetri AT parkyoungbae multicenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetri AT kimhyosoo multicenterprospectiverandomizedcontrolledtrialevaluatingthesafetyandefficacyofintracoronarycellinfusionmobilizedwithgranulocytecolonystimulatingfactoranddarbepoetinafteracutemyocardialinfarctionstudydesignandrationaleofthemagiccell5combinationcytokinetri |