Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
G-CSF (Dong-A pharmaceutical, Seoul, Korea)
collection of mobilized peripheral blood stem cells
Intracoronary infusion of mobilized cells
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, revascularization, drug eluting stents
Eligibility Criteria
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.
Sites / Locations
- Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu
Outcomes
Primary Outcome Measures
the change in left ventricular ejection fraction (LVEF), which was measured by cardiac MRI
Secondary Outcome Measures
changes in left ventricular volume measured by echocardiography and MRI, myocardial perfusion by coronary flow reserve, and the development of major adverse cardiac events
Full Information
NCT ID
NCT00291629
First Posted
February 13, 2006
Last Updated
September 6, 2007
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00291629
Brief Title
Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES
Official Title
Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES (MAGIC Cell-3-DES)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, revascularization, drug eluting stents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
G-CSF (Dong-A pharmaceutical, Seoul, Korea)
Intervention Type
Procedure
Intervention Name(s)
collection of mobilized peripheral blood stem cells
Intervention Type
Procedure
Intervention Name(s)
Intracoronary infusion of mobilized cells
Primary Outcome Measure Information:
Title
the change in left ventricular ejection fraction (LVEF), which was measured by cardiac MRI
Time Frame
6 month
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, MD
Organizational Affiliation
Associated Professor of Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
15016484
Citation
Kang HJ, Kim HS, Zhang SY, Park KW, Cho HJ, Koo BK, Kim YJ, Soo Lee D, Sohn DW, Han KS, Oh BH, Lee MM, Park YB. Effects of intracoronary infusion of peripheral blood stem-cells mobilised with granulocyte-colony stimulating factor on left ventricular systolic function and restenosis after coronary stenting in myocardial infarction: the MAGIC cell randomised clinical trial. Lancet. 2004 Mar 6;363(9411):751-6. doi: 10.1016/S0140-6736(04)15689-4.
Results Reference
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Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES
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