## Protocol Section
### Identification Module
**NCT ID:** NCT00307879

**Brief Title:** Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion

**Official Title:** Phase 2 MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion) Trial

#### Organization Study ID Info
**ID:** SNUH-MAGIC1
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2005-02

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2006-03-28

**Type:** ESTIMATED

**Last Update Submit Date:** 2006-03-27

**Overall Status:** TERMINATED

#### Start Date
**Date:** 2004-03

**Status Verified Date:** 2004-03

#### Study First Post Date
**Date:** 2006-03-28
**Type:** ESTIMATED
**Study First Submit Date:** 2006-03-27
**Study First Submit QC Date:** 2006-03-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University Hospital

### Description Module

**Brief Summary:** This trial was performed to evaluate the safety and the efficacy of G-CSF based stem cell therapy in patients with AMI. MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction, and had two groups of cell infusion, and G-CSF alone. MAGIC Cell-2 trial enrolled patients with acute myocardial infarction presented within 12 hours after onset of chest pain who underwent successful primary PCI. We randomized patients into the G-CSF group and the control group.

**Detailed Description:** We compared intra-coronary infusion of the mobilized PBSCs with G-CSF (n=10) and mobilization alone with G-CSF (n=10) in patients with myocardial infarction in MAGIC Cell -1 trial and G-CSF alone (n=6) and control (n=6) in MAGIC Cell-2 trial.

This study was a randomized, controlled phase II clinical trial. The Institutional Review Board of Seoul National University Hospital approved the study protocol. The informed written consents were obtained from patients after explaining the procedure and risk.

This study consisted of 2 sub-studies; MAGIC Cell (Myocardial Regeneration and Angiogenesis in Myocardial Infarction with G-CSF and Intra-Coronary Stem Cell Infusion)-1 and 2 trial.

In brief, MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction, and had two groups of cell infusion, and G-CSF alone. PBSCs were mobilized by daily subcutaneous injections of G-CSF (Dong-A pharmaceutical, Seoul, Korea) with 10 g/kg body weight for four days before percutaneous coronary intervention (PCI). After completion of G-CSF injection, all patients underwent PCI and implantation of stents for the culprit lesion of infarct related artery. Immediately after PCI, patients in the cell infusion group received intra-coronary infusion of the collected PBSC, which were mobilized and collected before PCI. The enrollment of patients to MAGIC Cell-1 trial was terminated prematurely due to potential adverse reaction of increased restenosis. However, follow up of the enrolled patients were completed until 1 year as scheduled. MAGIC Cell-2 trial enrolled patients with acute myocardial infarction presented within 12 hours after onset of chest pain who underwent successful primary PCI. We randomized patients into the G-CSF group and the control group. The patients in the G-CSF group received G-CSF of 10 g/kg body weight for four days at least 24hours after primary PCI. The enrollment of patients to MAGIC Cell-2 trial was also terminated prematurely due to potential adverse reaction of increased restenosis reported in MAGIC Cell-1 trial. However, follow up of the enrolled patients were also completed until 1 year as scheduled

### Conditions Module

**Conditions:**

- Myocardial Infarction

**Keywords:**

- Myocardial infarction

- revascularization

- granulocyte colony stimulating factor (G-CSF)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Drug: G-CSF (Dong-A pharmaceutical, Seoul, Korea)

**Type:** DRUG

#### Intervention 2

**Name:** collection of mobilized peripheral blood stem cells

**Type:** PROCEDURE

#### Intervention 3

**Name:** Intracoronary infusion of mobilized cells

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** the change in left ventricular ejection fraction, measured by SPECT, echocardiography

#### Secondary Outcomes

**Measure:** changes in left ventricular volume by SPECT, echocardiography

**Measure:** the development of major adverse cardiac events

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* MAGIC Cell-1 trial enrolled patients with acute and old myocardial infarction
* MAGIC Cell-2 trial enrolled patients with acute myocardial infarction presented within 12 hours after onset of chest pain who underwent successful primary PCI.

Exclusion Criteria:

* Persistent severe heart failure (above Killip class II or LVEF \< 25 %)
* Uncontrolled myocardial ischemia or ventricular tachycardia
* Culprit lesion of infarct related artery not feasible for PCI or unsuccessful PCI
* Age \> 75 years
* Malignancy
* Serious current infection or hematologic disease
* Life expectancy under one year.

**Maximum Age:** 80 Years

**Minimum Age:** 0 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu

**Zip:** 110-744

#### Overall Officials

**Official 1:**

**Affiliation:** Associated Professor of Seoul National University Hospital

**Name:** Hyo-Soo Kim, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Kang HJ, Kim HS, Zhang SY, Park KW, Cho HJ, Koo BK, Kim YJ, Soo Lee D, Sohn DW, Han KS, Oh BH, Lee MM, Park YB. Effects of intracoronary infusion of peripheral blood stem-cells mobilised with granulocyte-colony stimulating factor on left ventricular systolic function and restenosis after coronary stenting in myocardial infarction: the MAGIC cell randomised clinical trial. Lancet. 2004 Mar 6;363(9411):751-6. doi: 10.1016/S0140-6736(04)15689-4.

**PMID:** 15016484

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12155

- Name: Myocardial Infarction

- Relevance: HIGH

- As Found: Myocardial Infarction

- ID: M10282

- Name: Infarction

- Relevance: HIGH

- As Found: Infarction

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000007238

- Term: Infarction

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1945

- Name: Lenograstim

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
