A ‘biological bypass’ appears safe for patients with coronary heart disease and shows promise, according to a breakthrough Finnish study.
The procedure involves an injection of a vascular growth factor into the heart muscle area to improve oxygen supply.
Researchers at University of Eastern Finland, Kuopio University Hospital and Turku PET Centre, say it is a significant step forward in the development of novel biological treatments for patients with severe coronary artery disease.
The randomised, blind, placebo-controlled phase 1/2a trial is the first in the world to use a novel vascular growth factor and researchers also developed a novel and precise method for injecting the gene into the oxygen-deficient heart muscle area.
This involved inserting a customised catheter via the patient’s groin vessels to the left ventricle, after which the gene solution can be injected directly into the heart muscle.
Writing in the European Heart Journal, the team says that the method is as straightforward to undertake as coronary balloon angioplasty.
The effects were apparent one year after treatment, which enhances circulation in the oxygen-deficient heart muscle.
A new blood test biomarker was also discovered, making it possible to identify patients who are most likely to benefit from the new treatment, said Professor Seppo Ylä-Herttuala, who developed the biological bypass with his research group at the A.I. Virtanen Institute for Molecular Sciences of the University of Eastern Finland.
A 2b phase of research is to continue in 2018 after the study secured €6m of funding from the European Union.
This multi-centre trial will also include five other cardiology clinics from Denmark, the UK, Austria, Spain and Poland, and will be co-ordinated by the Kuopio University Hospital Heart Centre.
Hartikainen J, Hassinen I, Hedman A et al. Adenoviral intramyocardial VEGF-D gene transfer increases myocardial perfusion reserve in refractory angina patients. A phase I/IIa study with one year follow-up. European Heart Journal 31 July 2017; doi: 10.1093/eurheartj/ehx352 [abstract]
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