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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 €

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EC-Contrib. €

0

Partnership

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 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.

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

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 FI (KYS) coordinator 1˙962˙787.00
2    MEDIZINISCHE UNIVERSITAET WIEN AT (WIEN) participant 621˙668.00
3    FINVECTOR OY FI (KUOPIO) participant 616˙967.00
4    QUEEN MARY UNIVERSITY OF LONDON UK (LONDON) participant 610˙260.00
5    SLASKI UNIWERSYTET MEDYCZNY W KATOWICACH PL (KATOWICE) participant 591˙250.00
6    REGION HOVEDSTADEN DK (HILLEROD) participant 564˙182.00
7    SERVICIO MADRILENO DE SALUD ES (MADRID) participant 523˙021.00
8    A2F ASSOCIATES LIMITED UK (NEWMARKET) participant 301˙870.00
9    UNIVERSITY COLLEGE LONDON 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.

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

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