Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)

Myocardial Infarction Clinical Trial

Official title:

A Randomized Clinical Trial of Stem Cell Mobilization by Granulocyte-Colony-Stimulating Factor in Patients With Acute Myocardial Infarction. Regenerate Vital Myocardium by Vigorous Activation of Bone Marrow Stem Cells (REVIVAL-2) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126100
• Other study ID #: GE IDE No. I01003
• Secondary ID: KKF 10-02KKF 04-
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2005
• Last updated: November 23, 2007
• Start date: February 2004
• Est. completion date: July 2005

Study information

• Verified date: November 2007
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size.

Description:

Experimental studies and early-phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem cells that are available cells for myocardial regeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ST-elevation acute myocardial infarction (5 days before randomization)

• Successful percutaneous coronary intervention [PCI] (performed within 12 hours from symptom onset)

• Scintigraphic infarct size >5% of left ventricle

• Written informed consent

Exclusion Criteria:

• Age <18 years or >80 years

• Congestive heart failure defined as Killip class >2

• A history of myocardial infarction

• Electrical or hemodynamic instability

• Autoimmune diseases

• Fructose intolerance

• Malignancies

• Incompatibility of filgrastim

• Known or suspected pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• G-CSF Granulocyte-Colony Stimulating Factor
Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.

Other:
• Placebo
Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.

Locations

Country	Name	City	State
Germany	671. Medizinische Klinik, Klinikum rechts der Isar	Munich
Germany	Deutsches Herzzentrum	Munich

Sponsors (4)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Else Kröner Fresenius Foundation, Schulz Foundation, Wilhelm Sander Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Harada M, Qin Y, Takano H, Minamino T, Zou Y, Toko H, Ohtsuka M, Matsuura K, Sano M, Nishi J, Iwanaga K, Akazawa H, Kunieda T, Zhu W, Hasegawa H, Kunisada K, Nagai T, Nakaya H, Yamauchi-Takihara K, Komuro I. G-CSF prevents cardiac remodeling after myocardial infarction by activating the Jak-Stat pathway in cardiomyocytes. Nat Med. 2005 Mar;11(3):305-11. Epub 2005 Feb 20. — View Citation

Kocher AA, Schuster MD, Szabolcs MJ, Takuma S, Burkhoff D, Wang J, Homma S, Edwards NM, Itescu S. Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function. Nat Med. 2001 Apr;7(4):430-6. — View Citation

Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Mobilized bone marrow cells repair the infarcted heart, improving function and survival. Proc Natl Acad Sci U S A. 2001 Aug 28;98(18):10344-9. Epub 2001 Aug 14. — View Citation

Zohlnhöfer D, Ott I, Mehilli J, Schömig K, Michalk F, Ibrahim T, Meisetschläger G, von Wedel J, Bollwein H, Seyfarth M, Dirschinger J, Schmitt C, Schwaiger M, Kastrati A, Schömig A; REVIVAL-2 Investigators. Stem cell mobilization by granulocyte colony-sti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of infarct size (measured by Tc-sestamibi scintigraphy)		measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months
Secondary	Left ventricular ejection fraction		Left ventricular ejection fraction
Secondary	Incidence of angiographic restenosis		6 months