MAGIC Cell-5-Combicytokine Trial (MAGIC Cell-5)

• ClinicalTrials.gov Identifier: NCT00501917
• Recruitment Status: Unknown
• First Posted: July 16, 2007
• Last Update Posted: July 16, 2007
• Sponsor: Seoul National University Hospital
• Information provided by: Seoul National University Hospital

Tracking Information

• First Submitted Date: July 13, 2007
• First Posted Date: July 16, 2007
• Last Update Posted Date: July 16, 2007
• Study Start Date: March 2007
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: July 13, 2007): change of left ventricular ejection fraction measured by cardiac MRI [ Time Frame: 6, 12, and 24month ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: July 13, 2007): wall motion score index exercise capacity BNP [ Time Frame: 6,12, 24month ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MAGIC Cell-5-Combicytokine Trial
• Official Title: Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
• Brief Summary: Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Acute Myocardial Infarction
• Intervention: Drug: G-CSF with/without darbepoetin, peripheral blood stem cell infusion
• Study Arms: Not Provided

Publications *

• Kang HJ, Yoon EJ, Lee EJ, Kim MK, Suh JW, Park KW, Lee HY, Park KU, Cho YS, Koo BK, Chae IH, Choi DJ, Han KS, Kim HS, Park YB. Cotreatment with darbepoetin and granulocyte colony-stimulating factor is efficient to recruit proangiogenic cell populations in patients with acute myocardial infarction. Cell Transplant. 2012;21(5):1055-61. doi: 10.3727/096368911X627499. Epub 2012 Mar 22.
• Kang HJ, Kim MK, Kim MG, Choi DJ, Yoon JH, Park YB, Kim HS. A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'. Trials. 2011 Feb 7;12:33. doi: 10.1186/1745-6215-12-33.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 13, 2007): 116
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2010
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• ST elevation acute myocardial infarction
• < 80years
• successful revascularization of culprit vessel

Exclusion Criteria:

• uncontrolled congestive heart failure
• uncontrolled myocardial ischemia
• uncontrolled ventricular arrhythmia
• malignancy
• serious hematologic disease
• chronic renal failure

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00501917
• Other Study ID Numbers: MAGIC Cell-5
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Seoul National University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hyo-Soo Kim, MD PhD; Seoul National University Hospital

• PRS Account: Seoul National University Hospital
• Verification Date: July 2007