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. Fields of science medical and health sciencesmedical biotechnologygenetic engineeringgene therapymedical and health sciencesclinical medicinesurgerymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health sciencesclinical medicineradiologynuclear medicinemedical and health sciencesmedical biotechnologycells technologiesstem cells Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SC1-PM-11-2016-2017 - Clinical research on regenerative medicine Call for proposal H2020-SC1-2016-2017 See other projects for this call Sub call H2020-SC1-2016-RTD Funding Scheme RIA - Research and Innovation action 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 Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (10) Sort alphabetically Sort by Net EU contribution Expand all Collapse all 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 Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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 Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,25 MEDIZINISCHE UNIVERSITAET WIEN Austria Net EU contribution € 621 668,00 Address Spitalgasse 23 1090 Wien See on map Region Ostösterreich Wien Wien Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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 Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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 Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,25
