Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES

September 6, 2007 updated by: Seoul National University Hospital

Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES (MAGIC Cell-3-DES)

This trial was performed to evaluate the safety of G-CSF based stem cell therapy and to compare outcome of intracoronary infusion of mobilized PBSCs between patients with AMI and OMI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The MAGIC Cell-DES trial was designed as a randomized, controlled trial to recruit 100 patients with AMI and OMI. Patients who were successfully revascularized with DES in the culprit lesion were eligible for enrollment. After revascularization, patients were randomized by use of a randomization table. After randomization, study processes were not blinded.

In the cell infusion groups after successful PCI, PBSCs were mobilized by daily subcutaneous injections of G-CSF (Dong-A pharmaceutical, Seoul, Korea) at 10 g/kg body weight for three days. At day 4, mobilized PBSCs were collected with COBE spectra apheresis system (COBE BCT. Inc., Lakewood, CO, USA) using the mononuclear cell collection methods and infused selectively to infarcted myocardium via over-the-wire balloon catheter.

The primary end point to evaluate efficacy was the change in LVEF, measured by MRI. The secondary end points were changes in LV volume, myocardial perfusion measured by coronary flow reserve (CFR), and the development of major adverse cardiac events (MACE; death, new MI, revascularization, hospitalization due to aggravation of ischemia or heart failure).

Study Type

Interventional

Enrollment (Actual)

96

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

No older than 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute or old myocardial infarction who were successfully revascularized with DES in the culprit lesion were eligible for enrollment.

Exclusion Criteria:

  • 1) Persistent severe heart failure (left ventricular ejection fraction (LVEF) < 20%) 2) Uncontrolled myocardial ischemia or ventricular tachycardia 3) Culprit lesion of infarct related artery not feasible for percutaneous coronary intervention (PCI) or unsuccessful PCI 4) Age > 80 years 5) Malignancy 6) Serious current infection or hematologic disease; and 7) 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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the change in left ventricular ejection fraction (LVEF), which was measured by cardiac MRI
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in left ventricular volume measured by echocardiography and MRI, myocardial perfusion by coronary flow reserve, and the development of major adverse cardiac events
Time Frame: 6month
6month

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

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 13, 2006

First Posted (ESTIMATE)

February 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2007

Last Update Submitted That Met QC Criteria

September 6, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SeoulNUH cardiology

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.

Subscribe