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MAGIC Cell-5-Combicytokine Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00501917
First received: July 13, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

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

Further study details as provided by Seoul National University Hospital:

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

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

Estimated Enrollment: 116
Study Start Date: March 2007
Estimated Study Completion Date: February 2010
  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00501917     History of Changes
Other Study ID Numbers: MAGIC Cell-5
Study First Received: July 13, 2007
Last Updated: July 13, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013