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

Primary Purpose

Ischemic Heart Disease

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

VEGF-A165 plasmid

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Gene therapy, VEGF, Stem cells, myocardial ischemia, angiogenesis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet

Outcomes

Primary Outcome Measures

Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)

Secondary Outcome Measures

Clinical improvement

Full Information

NCT ID

NCT00135850

First Posted

August 25, 2005

Last Updated

August 4, 2011

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00135850

Brief Title

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

2. Study Status

Record Verification Date

October 2002

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

February 2005 (Actual)

Study Completion Date

February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

Keywords

Gene therapy, VEGF, Stem cells, myocardial ischemia, angiogenesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (false)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

VEGF-A165 plasmid

Primary Outcome Measure Information:

Title

Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)

Secondary Outcome Measure Information:

Title

Clinical improvement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jens Kastrup, MD DMSc

Organizational Affiliation

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet, DK-2100 Copenhagen Ø, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet

City

Copenhagen Ø

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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