Abstract | BACKGROUND: 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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Authors | Hyun-Jae Kang, Min-Kyung Kim, Myung-Gon Kim, Dong-Ju Choi, Jung-Han Yoon, Young-Bae Park, Hyo-Soo Kim |
Journal | Trials
(Trials)
Vol. 12
Pg. 33
(Feb 07 2011)
ISSN: 1745-6215 [Electronic] England |
PMID | 21299845
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cytokines
- Hematinics
- Erythropoietin
- Granulocyte Colony-Stimulating Factor
- Darbepoetin alfa
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Topics |
- Combined Modality Therapy
- Cytokines
(therapeutic use)
- Darbepoetin alfa
- Erythropoietin
(analogs & derivatives, therapeutic use)
- Follow-Up Studies
- Granulocyte Colony-Stimulating Factor
(therapeutic use)
- Hematinics
(therapeutic use)
- Hematopoietic Stem Cell Mobilization
(adverse effects, methods)
- Hematopoietic Stem Cell Transplantation
(adverse effects, methods)
- Humans
- Injections
- Myocardial Infarction
(therapy)
- Prospective Studies
- Research Design
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