Clinical trial NCT00135850: The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris
Official title: The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ischemic Heart Disease
Keywords: Gene therapy
VEGF
Stem cells
myocardial ischemia
angiogenesis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)
Secondary outcomes:
measure: Clinical improvement
Other outcomes:
Locations:
city: Copenhagen Ø
country: Denmark
facility: Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet
Study officials:
affiliation: Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet, DK-2100 Copenhagen Ø, Denmark
name: Jens Kastrup, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References: