Skip to main content

Clinical development and proof of principle testing of new regenerative VEGF-D therapy for cost-effective treatment of refractory angina A 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.

Field of science

  • /medical and health sciences/clinical medicine/surgery
  • /medical and health sciences/medical biotechnology/genetic engineering/gene therapy
  • /social sciences/sociology/demography/mortality

Call for proposal

H2020-SC1-2016-RTD
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

POHJOIS-SAVON SAIRAANHOITOPIIRIN KUNTAYHTYMA
Address
Pl 100
70029 Kys
Finland
Activity type
Research Organisations
EU contribution
€ 1 962 787

Participants (8)

QUEEN MARY UNIVERSITY OF LONDON
United Kingdom
EU contribution
€ 610 260
Address
327 Mile End Road
E1 4NS London
Activity type
Higher or Secondary Education Establishments
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 142 081
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE UNIVERSITAET WIEN
Austria
EU contribution
€ 621 668
Address
Spitalgasse 23
1090 Wien
Activity type
Higher or Secondary Education Establishments
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 523 021
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
FINVECTOR OY
Finland
EU contribution
€ 616 967
Address
Microkatu 1 S
70210 Kuopio
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SLASKI UNIWERSYTET MEDYCZNY W KATOWICACH
Poland
EU contribution
€ 591 250
Address
Ul. Poniatowskiego 15
40 055 Katowice
Activity type
Higher or Secondary Education Establishments
REGION HOVEDSTADEN
Denmark
EU contribution
€ 564 182
Address
Kongens Vaenge 2
3400 Hillerod
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
A2F ASSOCIATES LIMITED
United Kingdom
EU contribution
€ 301 870
Address
7 Laureate Paddocks
CB8 0AP Newmarket
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)