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MAGIC Cell-5-Combicytokine Trial (MAGIC Cell-5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00501917
Recruitment Status : Unknown
Verified July 2007 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : July 16, 2007
Last Update Posted : July 16, 2007
Sponsor:
Information provided by:
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 13, 2007
First Posted Date  ICMJE July 16, 2007
Last Update Posted Date July 16, 2007
Study Start Date  ICMJE March 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2007)
change of left ventricular ejection fraction measured by cardiac MRI [ Time Frame: 6, 12, and 24month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2007)
wall motion score index exercise capacity BNP [ Time Frame: 6,12, 24month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MAGIC Cell-5-Combicytokine Trial
Official Title  ICMJE Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
Brief Summary Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE Drug: G-CSF with/without darbepoetin, peripheral blood stem cell infusion
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 13, 2007)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ST elevation acute myocardial infarction
  • < 80years
  • successful revascularization of culprit vessel

Exclusion Criteria:

  • uncontrolled congestive heart failure
  • uncontrolled myocardial ischemia
  • uncontrolled ventricular arrhythmia
  • malignancy
  • serious hematologic disease
  • chronic renal failure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00501917
Other Study ID Numbers  ICMJE MAGIC Cell-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hyo-Soo Kim, MD PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP