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

March 27, 2006 updated by: Seoul National University Hospital

Phase 2 MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion) Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the change in left ventricular ejection fraction, measured by SPECT, echocardiography

Secondary Outcome Measures

Outcome Measure
changes in left ventricular volume by SPECT, echocardiography
the development of major adverse cardiac events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion

December 7, 2022

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

March 28, 2006

Last Update Submitted That Met QC Criteria

March 27, 2006

Last Verified

March 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-MAGIC1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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