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

Phase 2

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT00291629
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-14
• Study Completion: 2007-08
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-06
• Last Update Posted: 2007-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the change in left ventricular ejection fraction (LVEF), which was measured by cardiac MRI	6 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu; 🇰🇷 Seoul, Korea, Republic of