MAGIC Cell-5-Combicytokine Trial

Acute Myocardial Infarction Clinical Trial

— MAGIC Cell-5  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00501917
• Other study ID #: MAGIC Cell-5
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 13, 2007
• Last updated: July 13, 2007
• Start date: March 2007
• Est. completion date: February 2010

Study information

• Verified date: July 2007
• Source: Seoul National University Hospital
• Contact: Hyo-Soo Kim, MD PhD
• Phone: 82-2-2072-2226
• Email: hyosoo[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• G-CSF with/without darbepoetin, peripheral blood stem cell infusion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univesity Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of left ventricular ejection fraction measured by cardiac MRI		6, 12, and 24month
Secondary	wall motion score index exercise capacity BNP		6,12, 24month