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MAGIC Cell-5-Combicytokine Trial (MAGIC Cell-5)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Seoul National University Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00501917
First received: July 13, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | July 13, 2007 | |||
| Last Updated Date | July 13, 2007 | |||
| Start Date ICMJE | March 2007 | |||
| Primary Completion Date | Not Provided | |||
| Current Primary Outcome Measures ICMJE |
change of left ventricular ejection fraction measured by cardiac MRI [ Time Frame: 6, 12, and 24month ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | No Changes Posted | |||
| Current Secondary Outcome Measures ICMJE |
wall motion score index exercise capacity BNP [ Time Frame: 6,12, 24month ] | |||
| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | MAGIC Cell-5-Combicytokine Trial | |||
| Official Title ICMJE | 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 ICMJE | Interventional | |||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Acute Myocardial Infarction | |||
| Intervention ICMJE | Drug: G-CSF with/without darbepoetin, peripheral blood stem cell infusion | |||
| Study Arms | Not Provided | |||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Unknown status | |||
| Estimated Enrollment ICMJE | 116 | |||
| Estimated Completion Date | February 2010 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 15 Years to 80 Years (Child, Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Korea, Republic of | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00501917 | |||
| Other Study ID Numbers ICMJE | MAGIC Cell-5 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Seoul National University Hospital | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Seoul National University Hospital | |||
| Verification Date | July 2007 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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