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Adenovirus Vector Serotype 5 Containing The Vascular Endothelial Growth Factor D Isoform (Preprocessed Short Form)

This article discusses a phase II clinical trial investigating the use of Adenovirus Vector Serotype 5 Containing The Vascular Endothelial Growth Factor D Isoform (AdVEGF-D) as a potential treatment for severe coronary artery disease. The study aims to evaluate the safety and effectiveness of this innovative gene therapy approach for patients with refractory angina who are not suitable candidates for traditional revascularization procedures.

Table of Contents

What is VEGF-D Gene Therapy?

VEGF-D gene therapy is an innovative treatment being studied for patients with severe coronary artery disease, particularly those suffering from refractory angina. This therapy uses a modified virus called AdVEGF-D Delta N Delta C, also known as AdsVEGF-D, to deliver a gene that promotes the growth of new blood vessels in the heart[1].

How Does VEGF-D Gene Therapy Work?

The treatment involves injecting a specially designed adenovirus (a type of virus that has been modified for medical use) directly into the heart muscle. This virus carries a gene that produces a protein called Vascular Endothelial Growth Factor D (VEGF-D). VEGF-D stimulates the growth of new blood vessels, a process known as angiogenesis. By promoting the growth of new blood vessels, this therapy aims to improve blood flow to areas of the heart that are not receiving enough oxygen due to blocked or narrowed arteries[1].

Who Can Benefit from This Treatment?

This therapy is being developed for patients with severe coronary artery disease who experience persistent chest pain (angina) despite optimal medication. Specifically, it’s intended for those who:

  • Have significant angina (rated as CCS 2-3 on a scale that measures chest pain severity)
  • Have significant narrowing (60% or more) in their coronary arteries
  • Cannot undergo traditional treatments like bypass surgery (CABG) or angioplasty (PCI) due to the nature of their artery blockages
  • Experience chest pain during a 6-minute walking test

These patients are often described as having refractory angina, meaning their chest pain persists despite standard treatments[1].

The ReGenHeart Clinical Trial

The VEGF-D gene therapy is currently being studied in a clinical trial called ReGenHeart. This is a Phase II randomized, double-blinded, placebo-controlled study. Here are some key points about the trial:

  • It aims to evaluate the safety and effectiveness of the VEGF-D gene therapy in patients with refractory angina
  • Participants are randomly assigned to receive either the actual treatment or a placebo
  • Neither the patients nor the doctors know who is receiving the real treatment (this is what “double-blinded” means)
  • The study will measure improvements in patients’ ability to exercise, their symptoms, quality of life, and the safety of the treatment

To participate in the trial, patients must meet specific criteria, including being between 30 and 85 years old and having a certain level of heart function[1].

Potential Benefits of VEGF-D Gene Therapy

The researchers hope that this therapy will provide several benefits for patients with severe coronary artery disease:

  1. Improved exercise capacity: Measured by how far patients can walk in 6 minutes
  2. Reduced angina symptoms: Assessed using the Canadian Cardiovascular Society (CCS) classification
  3. Better heart blood flow: Evaluated through tests that measure heart perfusion
  4. Enhanced quality of life: By reducing chest pain and improving overall heart function

These potential benefits could significantly improve the daily lives of patients who have exhausted other treatment options[1].

Safety Considerations

As with any new medical treatment, safety is a top priority. The ReGenHeart trial has specific criteria to ensure patient safety:

  • Patients with certain conditions are excluded, such as those with severe heart failure, recent heart attacks, or strokes
  • People with current or suspected cancer cannot participate
  • Patients with severe complications from diabetes, significant anemia, or kidney problems are also excluded
  • The trial monitors for any side effects or complications throughout the study

It’s important to note that this is still an experimental treatment, and its long-term effects are not yet fully known[1].

Aspect Details
Study Type Phase II randomized, double-blinded, placebo-controlled study
Intervention AdVEGF-D regenerative gene transfer
Target Population Patients with refractory angina unsuitable for revascularization
Primary Objectives Evaluate safety and efficacy of gene therapy
Secondary Objectives Assess effects on myocardial perfusion, symptoms, and quality of life
Key Inclusion Criteria Age 30-85, significant angina (CCS 2-3), coronary stenosis ≥60%
Key Exclusion Criteria Recent acute coronary events, severe left ventricular dysfunction, malignancy
Primary Endpoints Improvement in 6-minute walking test and CCS class
Administration Route Intracardiac use

FAQ

  • What is the purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the safety and efficacy of catheter-mediated AdVEGF-D regenerative gene transfer in patients with refractory angina who cannot undergo revascularization procedures.
  • Who is eligible to participate in this study? Eligible participants are adults aged 30-85 years with significant angina pectoris (CCS 2-3) despite optimal medication, significant coronary artery stenosis, and contraindications to traditional revascularization procedures like CABG or PCI.
  • What are the main outcomes being measured in this trial? The primary outcomes include improvement in functional capacity using the 6-minute walking test and improvement of symptoms assessed by the Canadian Cardiovascular Society (CCS) class.
  • How is the gene therapy administered? The gene therapy is administered through intracardiac use, which means it is delivered directly to the heart using a catheter-mediated approach.
  • What are some of the exclusion criteria for this study? Some key exclusion criteria include women of childbearing potential, recent acute coronary events, significant impairment of left ventricular function, current or suspected malignancy, and severe complications of diabetes mellitus.

Ongoing Clinical Trials on Adenovirus Vector Serotype 5 Containing The Vascular Endothelial Growth Factor D Isoform (Preprocessed Short Form)

  • Gene Therapy Study for Severe Coronary Artery Disease Using AdsVEGF-D Delta N Delta C in Patients with Refractory Angina

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Denmark Finland

Glossary

  • Refractory Angina: A chronic condition characterized by persistent chest pain (angina) that is not relieved by standard treatments such as medication or revascularization procedures.
  • VEGF-D: Vascular Endothelial Growth Factor D, a protein that stimulates the growth of new blood vessels, potentially improving blood flow to the heart.
  • Adenovirus Vector: A modified virus used to deliver genetic material (in this case, VEGF-D) to specific cells in the body.
  • Gene Therapy: A technique that uses genes to treat or prevent disease by introducing genetic material into a patient's cells.
  • Revascularization: A procedure to restore blood flow to an organ or tissue, typically referring to the heart in the context of coronary artery disease.
  • CABG: Coronary Artery Bypass Grafting, a surgical procedure to improve blood flow to the heart by creating new routes around narrowed or blocked arteries.
  • PCI: Percutaneous Coronary Intervention, a non-surgical procedure used to open narrowed coronary arteries, often involving the placement of a stent.
  • CCS Class: Canadian Cardiovascular Society Angina Classification, a system used to grade the severity of angina symptoms.
  • Myocardial Perfusion: The process of delivering blood to the heart muscle (myocardium) through the coronary arteries.
  • Intracardiac Use: Administration of a treatment directly into the heart, typically using a catheter-based approach.

References

  1. http://clinicaltrials.eu/trial/gene-therapy-study-for-severe-coronary-artery-disease-using-adsvegf-d-delta-n-delta-c-in-patients-with-refractory-angina/