Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion
Phase 2 MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion) Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
This trial was performed to evaluate the safety and the efficacy of G-CSF based stem cell therapy in patients with AMI. MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction, and had two groups of cell infusion, and G-CSF alone. MAGIC Cell-2 trial enrolled patients with acute myocardial infarction presented within 12 hours after onset of chest pain who underwent successful primary PCI. We randomized patients into the G-CSF group and the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2004
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 28, 2006
CompletedMarch 28, 2006
March 1, 2004
March 27, 2006
March 27, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the change in left ventricular ejection fraction, measured by SPECT, echocardiography
Secondary Outcomes (2)
changes in left ventricular volume by SPECT, echocardiography
the development of major adverse cardiac events
Interventions
Eligibility Criteria
You may qualify if:
- MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction
- MAGIC Cell-2 trial enrolled patients with acute myocardial infarction presented within 12 hours after onset of chest pain who underwent successful primary PCI.
You may not qualify if:
- Persistent severe heart failure (above Killip class II or LVEF \< 25 %)
- Uncontrolled myocardial ischemia or ventricular tachycardia
- Culprit lesion of infarct related artery not feasible for PCI or unsuccessful PCI
- Age \> 75 years
- Malignancy
- Serious current infection or hematologic disease
- Life expectancy under one year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu
Seoul, Seoul, 110-744, South Korea
Related Publications (1)
Kang HJ, Kim HS, Zhang SY, Park KW, Cho HJ, Koo BK, Kim YJ, Soo Lee D, Sohn DW, Han KS, Oh BH, Lee MM, Park YB. Effects of intracoronary infusion of peripheral blood stem-cells mobilised with granulocyte-colony stimulating factor on left ventricular systolic function and restenosis after coronary stenting in myocardial infarction: the MAGIC cell randomised clinical trial. Lancet. 2004 Mar 6;363(9411):751-6. doi: 10.1016/S0140-6736(04)15689-4.
PMID: 15016484RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo-Soo Kim, MD
Associated Professor of Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 27, 2006
First Posted
March 28, 2006
Study Start
March 1, 2004
Study Completion
February 1, 2005
Last Updated
March 28, 2006
Record last verified: 2004-03