Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291629
Status:
COMPLETED
Last Update Posted:
2007-09-10
First Post:
2006-02-13
Brief Title:
Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES MAGIC Cell-3-DES
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 gkg 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
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 gkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None