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

Primary Purpose

Acute Myocardial Infarction

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute myocardial infarction

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National Univesity HospitalRecruiting

Outcomes

Primary Outcome Measures

change of left ventricular ejection fraction measured by cardiac MRI

Secondary Outcome Measures

wall motion score index exercise capacity BNP

Full Information

NCT ID

NCT00501917

First Posted

July 13, 2007

Last Updated

July 13, 2007

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00501917

Brief Title

MAGIC Cell-5-Combicytokine Trial

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

Keywords

acute myocardial infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

change of left ventricular ejection fraction measured by cardiac MRI

Time Frame

6, 12, and 24month

Secondary Outcome Measure Information:

Title

wall motion score index exercise capacity BNP

Time Frame

6,12, 24month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyo-Soo Kim, MD PhD

Phone

82-2-2072-2226

hyosoo@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun-Jae Kang, MD PhD

Phone

82-2-2072-2279

nowkang@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyo-Soo Kim, MD PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National Univesity Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

22449332

Citation

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.

Results Reference

derived

PubMed Identifier

21299845

Citation

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.

Results Reference

derived

Learn more about this trial

MAGIC Cell-5-Combicytokine Trial

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