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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:

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: G-CSF with/without darbepoetin, peripheral blood stem cell infusion Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2007
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. change of left ventricular ejection fraction measured by cardiac MRI [ Time Frame: 6, 12, and 24month ]

Secondary Outcome Measures :
  1. wall motion score index exercise capacity BNP [ Time Frame: 6,12, 24month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501917


Contacts
Contact: Hyo-Soo Kim, MD PhD 82-2-2072-2226 hyosoo@snu.ac.kr
Contact: Hyun-Jae Kang, MD PhD 82-2-2072-2279 nowkang@snu.ac.kr

Locations
Korea, Republic of
Seoul National Univesity Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyo-Soo Kim, MD PhD Seoul National University Hospital
More Information