MAGIC Cell-5-Combicytokine Trial | NCT00501917

Studies
MAGIC Cell-5-Combicytokine Trial

NCT00501917

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 16, 2007Estimated

Enrollment

116Estimated

Phase

Phase 2Phase 3

Conditions

Acute Myocardial Infarction

Interventions

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

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Feb 2010Estimated

First Submitted Date

Jul 13, 2007

First Submission Date that Met QC Criteria

Jul 13, 2007

First Posted Date

Jul 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2007

Last Update Posted Date

Jul 16, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

116Estimated

Name	Type	Description	Arm Group Labels	Other Names
G-CSF with/without darbepoetin, peripheral blood stem cell infusion	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of left ventricular ejection fraction measured by cardiac MRI		6, 12, and 24month

Secondary Outcomes

Measure	Description	Time Frame
wall motion score index exercise capacity BNP		6,12, 24month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyo-Soo Kim, MD PhD	Contact	82-2-2072-2226		hyosoo@snu.ac.kr
Hyun-Jae Kang, MD PhD	Contact	82-2-2072-2279		nowkang@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Hyo-Soo Kim, MD PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National Univesity Hospital	Recruiting	Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22449332	Derived	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.
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