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 seven clinical centres. 120 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.

Call for proposal

H2020-SC1-2016-2017

See other projects for this call

Sub call

H2020-SC1-2016-RTD

Coordinator

POHJOIS-SAVON SAIRAANHOITOPIIRIN KUNTAYHTYMA
Net EU contribution
€ 1 478 193,00
Address
Pl 100
70029 Kys
Finland

See on map

Region
Manner-Suomi Pohjois- ja Itä-Suomi Pohjois-Savo
Activity type
Research Organisations
Non-EU contribution
€ 0,00

Participants (10)

QUEEN MARY UNIVERSITY OF LONDON
United Kingdom
Net EU contribution
€ 687 261,00
Address
327 Mile End Road
E1 4NS London

See on map

Region
London Inner London — East Tower Hamlets
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,25
UNIVERSITY COLLEGE LONDON
United Kingdom
Net EU contribution
€ 65 081,00
Address
Gower Street
WC1E 6BT London

See on map

Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,25
MEDIZINISCHE UNIVERSITAET WIEN
Austria
Net EU contribution
€ 621 668,00
Address
Spitalgasse 23
1090 Wien

See on map

Region
Wien Wien
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,75
SERVICIO MADRILENO DE SALUD
Spain
Net EU contribution
€ 523 021,00
Address
Plaza Carlos Trias Bertran 7
28020 Madrid

See on map

Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,25
FINVECTOR OY
Finland
Net EU contribution
€ 616 967,00
Address
Microkatu 1 S
70210 Kuopio

See on map

Region
Manner-Suomi Pohjois- ja Itä-Suomi Pohjois-Savo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,50
SLASKI UNIWERSYTET MEDYCZNY W KATOWICACH
Poland
Net EU contribution
€ 471 250,00
Address
Ul. Poniatowskiego 15
40 055 Katowice

See on map

Region
Makroregion południowy Śląskie Katowicki
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

GORNOSLASKIE CENTRUM MEDYCZNE IM. PROF. LESZKA GIECA SLASKIEGO UNIWERSYTETU MEDYCZNEGO W KATOWICACH
Poland
Net EU contribution
€ 120 000,00
Address
Ul Ziolowa 45-47
40 635 Katowice

See on map

Region
Makroregion południowy Śląskie Katowicki
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
REGION HOVEDSTADEN
Denmark
Net EU contribution
€ 564 182,00
Address
Kongens Vaenge 2
3400 Hillerod

See on map

Region
Danmark Hovedstaden Nordsjælland
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,50
A2F ASSOCIATES LIMITED
United Kingdom
Net EU contribution
€ 301 870,00
Address
7 Laureate Paddocks
CB8 0AP Newmarket

See on map

SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
East of England East Anglia Suffolk
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
SZPITAL KLINICZNY PRZEMIENIENIA PANSKIEGO UNIWERSYTETU MEDYCZNEGO IM. KAROLA MARCINKOWSKIEGO W POZNANIU
Poland
Net EU contribution
€ 484 593,00
Address
Ul. Dluga 1/2
61-848 Poznan

See on map

Region
Makroregion północno-zachodni Wielkopolskie Miasto Poznań
Activity type
Research Organisations
Non-EU contribution
€ 0,25