Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory Angina Pectoris

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of catheter mediated endocardial adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D) regenerative gene transfer in patients with refractory angina to whom revascularisation cannot be performed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuopio University Hospital
• Collaborators: Euram Limited; FinVector Vision Therapies Oy; Medical University of Vienna; Medizinische Universitaet Wien; Queen Mary University of London; Rigshospitalet, Denmark; Servicio Madrileño de Salud, Madrid, Spain; Śląski Uniwersytet Medyczny w Katowicach; University College, London
• Treatments: Endothelial Growth Factors; Mitogens

Criteria

Inclusion Criteria:

• informed consent signed

• age > 30 but < 85 years

• significant angina pectoris (CCS 2-3) despite of optimal medication

• significant stenosis (> 60%) in coronary angiography (< 6 months)

• contraindication to CABG or PCI due to diffuse or distal stenosis, chronic total occlusion, vessels with difficult anatomy, stenosis with severe calcifications and stenosis in small vessels (<2.5 mm))

• angina pectoris or equivalent symptoms in the 6-minute walking exercise test

• left ventricle wall > 8 mm detected by transthoracic echocardiography or magnetic resonance imaging (treatment area)

Exclusion Criteria:

• women in fertile age

• diabetes mellitus with severe complications such as diabetic retinopathy or nephropathy

• clinically significant anemia (hemoglobin count < 120 mg/l in male, < 110 mg/l in female; hematocrit < 0.36), leukopenia (b-leukocyte count < 3.0x109/l), leukocytosis (b-leukocyte count > 12.0x109/l) or thrombocytopenia (b-thrombocyte count < 100x109/l)

• renal insufficiency (P-creatinine > 160 mg/l)

• liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal)

• haematuria of unknown origin

• severe hypertension (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg) or significant hypotension (systolic blood pressure < 90 mmHg)

• significant obesity (Body Mass Index > 35)

• acute infection

• immunosuppressive medication

• significant impairment of left ventricular function (ejection fraction < 25% in echocardiography)

• symptomatic congestive heart failure (New York Heart Association class 3-4)

• haemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery

• recent (< 6 weeks) acute coronary syndrome or myocardial infarction, PCI or CABG, stroke or transient ischemic attack (TIA)

• current or suspected malignancy