The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris

Ischemic Heart Disease Clinical Trial

Official title:

The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135850
• Other study ID #: Gene G-CSF
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 25, 2005
• Last updated: August 4, 2011
• Start date: March 2003
• Est. completion date: February 2005

Study information

• Verified date: October 2002
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the mobilization of non-haematopoietic mesenchymal and haematopoietic stem cells from the bone marrow with granulocyte colony stimulating factor (G-CSF) treatment alone and in combination with vascular endothelial growth factor (VEGF) gene therapy in patients with severe chronic occlusive coronary artery disease.

Description:

In recent clinical trials, vascular endothelial growth factor (VEGF) delivered as plasmid DNA percutaneously by a catheter-based, intramyocardial approach, have been demonstrated to be safe and to be associated with a reduction in angina and an increase in exercise time or an improvement in regional wall motion in "no-option patients" with chronic myocardial ischemia.

It has been demonstrated, that BM-derived stem cells mobilized by cytokines as granulocyte colony stimulating factor (G-CSF) were capable of regenerating the myocardial tissue, leading to improve the survival and cardiac function after myocardial infarction.

These data suggested that a combination therapy with exogenous administration of gene vascular growth factor combined with G-CSF mobilization of bone marrow stem cells might induce both angiogenesis and vasculogenesis in ischemic myocardium

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Reversible ischemia at an adenosine stress single photon emission computerized tomography (SPECT)

• A coronary arteriography demonstrating at least one main coronary vessel from which new collaterals/vessels could be supplied

• Age above 18 years

• Canadian Cardiovascular Society angina classification (CCS) > 3.

Exclusion Criteria:

• Ejection fraction <0.40

• Unstable angina pectoris

• Acute myocardial infarction within the last three months

• Diabetes mellitus with proliferative retinopathy

• Diagnosed or suspected cancer disease

• Chronic inflammatory disease

• Premenopausal women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Genetic:
• VEGF-A165 plasmid

Locations

Country	Name	City	State
Denmark	Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)
Secondary	Clinical improvement