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Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion

This study has been terminated.

Sponsored by: Seoul National University Hospital
Information provided by: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00307879
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: Drug: G-CSF (Dong-A pharmaceutical, Seoul, Korea)
Procedure: collection of mobilized peripheral blood stem cells
Procedure: Intracoronary infusion of mobilized cells
Phase II

MedlinePlus related topics:   Heart Attack   

ChemIDplus related topics:   Sargramostim    Granulocyte-macrophage colony-stimulating factor    Granulocyte colony-stimulating factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Phase 2 MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion) Trial

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • the change in left ventricular ejection fraction, measured by SPECT, echocardiography

Secondary Outcome Measures:
  • changes in left ventricular volume by SPECT, echocardiography
  • the development of major adverse cardiac events

Estimated Enrollment:   20
Study Start Date:   March 2004
Estimated Study Completion Date:   February 2005

Detailed Description:

We compared intra-coronary infusion of the mobilized PBSCs with G-CSF (n=10) and mobilization alone with G-CSF (n=10) in patients with myocardial infarction in MAGIC Cell -1 trial and G-CSF alone (n=6) and control (n=6) in MAGIC Cell-2 trial.

This study was a randomized, controlled phase II clinical trial. The Institutional Review Board of Seoul National University Hospital approved the study protocol. The informed written consents were obtained from patients after explaining the procedure and risk.

This study consisted of 2 sub-studies; MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction with G-CSF and Intra-Coronary Stem Cell Infusion)–1 and 2 trial.

In brief, MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction, and had two groups of cell infusion, and G-CSF alone. PBSCs were mobilized by daily subcutaneous injections of G-CSF (Dong-A pharmaceutical, Seoul, Korea) with 10 g/kg body weight for four days before percutaneous coronary intervention (PCI). After completion of G-CSF injection, all patients underwent PCI and implantation of stents for the culprit lesion of infarct related artery. Immediately after PCI, patients in the cell infusion group received intra-coronary infusion of the collected PBSC, which were mobilized and collected before PCI. The enrollment of patients to MAGIC Cell-1 trial was terminated prematurely due to potential adverse reaction of increased restenosis. However, follow up of the enrolled patients were completed until 1 year as scheduled. 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. The patients in the G-CSF group received G-CSF of 10 g/kg body weight for four days at least 24hours after primary PCI. The enrollment of patients to MAGIC Cell-2 trial was also terminated prematurely due to potential adverse reaction of increased restenosis reported in MAGIC Cell-1 trial. However, follow up of the enrolled patients were also completed until 1 year as scheduled

  Eligibility
Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307879

Locations
Korea, Republic of
Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu    
      Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators
Seoul National University Hospital

Investigators
Principal Investigator:     Hyo-Soo Kim, MD     Associated Professor of Seoul National University Hospital    
  More Information

(Official homepage of Seoul National University Hospital Cardiology)  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   SNUH-MAGIC1
First Received:   March 27, 2006
Last Updated:   March 27, 2006
ClinicalTrials.gov Identifier:   NCT00307879
Health Authority:   Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Myocardial infarction  
revascularization  
granulocyte colony stimulating factor (G-CSF)  

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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