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

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ClinicalTrials.gov Identifier: NCT00307879
Recruitment Status : Terminated
First Posted : March 28, 2006
Last Update Posted : March 28, 2006
Sponsor:
Information provided by:
Seoul National University Hospital

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.

Condition or disease Intervention/treatment 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 2

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


Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion) Trial
Study Start Date : March 2004
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

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




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

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


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

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): 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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00307879     History of Changes
Other Study ID Numbers: SNUH-MAGIC1
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: March 28, 2006
Last Verified: March 2004

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs