Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307879
Status:
TERMINATED
Last Update Posted:
2006-03-28
First Post:
2006-03-27
Brief Title:
Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Phase 2 MAGIC Cell Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion Trial
Status:
TERMINATED
Status Verified Date:
2004-03
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 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
Detailed Description:
We compared intra-coronary infusion of the mobilized PBSCs with G-CSF n10 and mobilization alone with G-CSF n10 in patients with myocardial infarction in MAGIC Cell -1 trial and G-CSF alone n6 and control n6 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 gkg 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 gkg 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
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 gkg 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 gkg 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 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