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ReGenHeart SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

ReGenHeart project word cloud

Explore the words cloud of the ReGenHeart project. It provides you a very rough idea of what is the project "ReGenHeart" about.

clinical extensive unfortunately class intramyocardial 12 heart individual follow optimized either final surgery medical mace disease refractory mri angiogenesis validation dose levels months gene annual pet therapeutic therapy suffers minutes ready safety endpoints procedure 4 debilitating pectoris trial quality six man percutaneous regenheart angina proof patient 180 burden hospitalizations patients subject substantial double feasibility arms multiple blinded primary relatively adenovegf randomized score mortality healthcare multicentre subgroup single angioplasty ccs efficient imaging reduce never benefits conduct mediated recruited endpoint lt suffer centres induce regenerative regulatory approval preclinical walk catheter service life health placebo chronic area

Project "ReGenHeart" data sheet

The following table provides information about the project.

Coordinator	POHJOIS-SAVON SAIRAANHOITOPIIRIN KUNTAYHTYMA Organization address address: PL 100 city: KYS postcode: 70029 website: www.kuh.fi contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Finland [FI]
Project website	https://www.regenheart.eu/
Total cost	5˙934˙088 €
EC max contribution	5˙934˙086 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-SC1-2016-RTD
Funding Scheme	RIA
Starting year	2017
Duration (year-month-day)	from 2017-01-01 to 2021-06-30

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	POHJOIS-SAVON SAIRAANHOITOPIIRIN KUNTAYHTYMA POHJOIS-SAVON SAIRAANHOITOPIIRIN KUNTAYHTYMA Organization address address: PL 100 city: KYS postcode: 70029 website: www.kuh.fi contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FI (KYS)	coordinator	1˙962˙787.00
2	MEDIZINISCHE UNIVERSITAET WIEN MEDIZINISCHE UNIVERSITAET WIEN Organization address address: SPITALGASSE 23 city: WIEN postcode: 1090 website: www.meduniwien.ac.at contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (WIEN)	participant	621˙668.00
3	FINVECTOR OY FINVECTOR OY Organization address address: MICROKATU 1 S city: KUOPIO postcode: 70210 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FI (KUOPIO)	participant	616˙967.00
4	QUEEN MARY UNIVERSITY OF LONDON QUEEN MARY UNIVERSITY OF LONDON Organization address address: 327 MILE END ROAD city: LONDON postcode: E1 4NS website: http://www.qmul.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	610˙260.00
5	SLASKI UNIWERSYTET MEDYCZNY W KATOWICACH SLASKI UNIWERSYTET MEDYCZNY W KATOWICACH Organization address address: UL. PONIATOWSKIEGO 15 city: KATOWICE postcode: 40 055 website: www.sum.edu.pl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	PL (KATOWICE)	participant	591˙250.00
6	REGION HOVEDSTADEN REGION HOVEDSTADEN Organization address address: KONGENS VAENGE 2 city: HILLEROD postcode: 3400 website: www.regionh.dk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (HILLEROD)	participant	564˙182.00
7	SERVICIO MADRILENO DE SALUD SERVICIO MADRILENO DE SALUD Organization address address: PLAZA CARLOS TRIAS BERTRAN 7 city: MADRID postcode: 28020 website: http://cort.as/10Yf contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (MADRID)	participant	523˙021.00
8	A2F ASSOCIATES LIMITED A2F ASSOCIATES LIMITED Organization address address: 7 LAUREATE PADDOCKS city: NEWMARKET postcode: CB8 0AP website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NEWMARKET)	participant	301˙870.00
9	UNIVERSITY COLLEGE LONDON UNIVERSITY COLLEGE LONDON Organization address address: GOWER STREET city: LONDON postcode: WC1E 6BT website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	142˙081.00

Map

Project 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.

Deliverables

List of deliverables.
Project website	Websites, patent fillings, videos etc.	2020-04-08 14:15:03

Take a look to the deliverables list in detail: detailed list of ReGenHeart deliverables.

Are you the coordinator (or a participant) of this project? Plaese send me more information about the "REGENHEART" project.

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Send me an email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.

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The information about "REGENHEART" are provided by the European Opendata Portal: CORDIS opendata.

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