CORDIS
EU research results

CORDIS

English EN
Clinical development and proof of principle testing of new regenerative VEGF-D therapy for cost-effective treatment of refractory anginaA phase II randomized, double-blinded, placebo-controlled study

Clinical development and proof of principle testing of new regenerative VEGF-D therapy for cost-effective treatment of refractory anginaA phase II randomized, double-blinded, placebo-controlled study

Objective

Chronic angina pectoris is a debilitating chronic disease, a subgroup of these patients suffers from refractory angina which unfortunately can’t be controlled by medical therapy (angioplasty or surgery). Refractory angina is a substantial burden on the individual and healthcare system, in Europe there are 100,000 new cases per year, annual mortality of these patients is relatively low (<4%) thus refractory angina patients suffer multiple hospitalizations and low levels of health-related quality of life.

The ReGenHeart project is based on extensive preclinical work and a phase I safety, feasibility and dose-finding clinical study recently completed by the consortium. The project will conduct a multicentre, randomized, placebo-controlled, double-blinded Phase II clinical study to provide proof of concept and clinical validation for a new, percutaneous, cost-efficient therapy for refractory angina patients. Using our optimized catheter-mediated intramyocardial approach with AdenoVEGF-D, which has never been used in man before our phase I trial, we aim to induce regenerative changes supported by therapeutic angiogenesis in the affected area of a patient's heart and, in a single procedure, reduce the burden on the individual and their health service.

The proposed trial is ready to proceed, subject to final regulatory approval in the six European clinical centres. 180 CCS class 2-3 refractory angina patients will be recruited, which will allow us to assess the benefits of therapy to patients who still have potential to respond to the regenerative therapy. Patients will be randomized 2:1 to either the gene therapy or placebo arms.

Trial follow up, at 6 and 12 months, will assess how far they can walk in 6 minutes (primary endpoint) and also by their CCS angina score, quality of life, so-called MACE endpoints and several advanced PET and MRI imaging endpoints.

Coordinator

POHJOIS-SAVON SAIRAANHOITOPIIRIN KUNTAYHTYMA

Address

Pl 100
70029 Kys

Finland

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 962 787

Participants (8)

Sort alphabetically

Sort by EU Contribution

Expand all

QUEEN MARY UNIVERSITY OF LONDON

United Kingdom

EU Contribution

€ 610 260

UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 142 081

MEDIZINISCHE UNIVERSITAET WIEN

Austria

EU Contribution

€ 621 668

SERVICIO MADRILENO DE SALUD

Spain

EU Contribution

€ 523 021

FINVECTOR OY

Finland

EU Contribution

€ 616 967

SLASKI UNIWERSYTET MEDYCZNY W KATOWICACH

Poland

EU Contribution

€ 591 250

REGION HOVEDSTADEN

Denmark

EU Contribution

€ 564 182

A2F ASSOCIATES LIMITED

United Kingdom

EU Contribution

€ 301 870

Project information

Grant agreement ID: 731532

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    30 June 2021

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 934 088,75

  • EU contribution

    € 5 934 086

Coordinated by:

POHJOIS-SAVON SAIRAANHOITOPIIRIN KUNTAYHTYMA

Finland