Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES

NCT00291629 | Completed Phase 2 DMC

• 1 other identifier: SeoulNUH cardiology
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was performed to evaluate the safety of G-CSF based stem cell therapy and to compare outcome of intracoronary infusion of mobilized PBSCs between patients with AMI and OMI.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; revascularization; drug eluting stents

Outcome Measures

Primary Outcomes (1)

• the change in left ventricular ejection fraction (LVEF), which was measured by cardiac MRI

  6 month

Secondary Outcomes (1)

• changes in left ventricular volume measured by echocardiography and MRI, myocardial perfusion by coronary flow reserve, and the development of major adverse cardiac events

  6month

Interventions

G-CSF (Dong-A pharmaceutical, Seoul, Korea) DRUG

collection of mobilized peripheral blood stem cells PROCEDURE

Intracoronary infusion of mobilized cells PROCEDURE

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute or old myocardial infarction who were successfully revascularized with DES in the culprit lesion were eligible for enrollment.

You may not qualify if:

• \) Persistent severe heart failure (left ventricular ejection fraction (LVEF) \< 20%) 2) Uncontrolled myocardial ischemia or ventricular tachycardia 3) Culprit lesion of infarct related artery not feasible for percutaneous coronary intervention (PCI) or unsuccessful PCI 4) Age \> 80 years 5) Malignancy 6) Serious current infection or hematologic disease; and 7) Life expectancy under one year.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital, Yon-Gon Dong, Chongno-Gu

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Hyo-Soo Kim, MD

  Associated Professor of Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 14, 2006
• Study Start: March 1, 2004
• Study Completion: August 1, 2007
• Last Updated: September 10, 2007

Record last verified: 2007-09

Locations

KR (1)