Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Drug: G-CSF (Dong-A pharmaceutical, Seoul, Korea) Procedure: collection of mobilized peripheral blood stem cells Procedure: Intracoronary infusion of mobilized cells |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES (MAGIC Cell-3-DES) |
- the change in left ventricular ejection fraction (LVEF), which was measured by cardiac MRI [ Time Frame: 6 month ]
- 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 ]
| Enrollment: | 96 |
| Study Start Date: | March 2004 |
| Study Completion Date: | August 2007 |
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).
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Korea, Republic of | |
| Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu | |
| Seoul, Korea, Republic of, 110-744 | |
| Principal Investigator: | Hyo-Soo Kim, MD | Associated Professor of Seoul National University Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00291629 History of Changes |
| Other Study ID Numbers: | SeoulNUH cardiology |
| Study First Received: | February 13, 2006 |
| Last Updated: | September 6, 2007 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Hospital:
|
Myocardial infarction revascularization drug eluting stents |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013