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ARISE SIGNED

Aortic Valve Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap

Total Cost €

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EC-Contrib. €

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Partnership

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 ARISE project word cloud

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

holds    auspicious    bedside    clinic    bench    diseases    anticoagulation    national    solutions    congenital    subject    extremely    heart    complexity    true    network    compassionate    34    valves    six    gap    regenerative    toward    limited    unclear    showing    regeneration    hampered    trials    unwilling    acquired    replacements    frequently    65    cardio    extensive    arise    medicine    thoracic    clinical    initial    life    haverich    valve    adds    inherent    paths    proven    human    prostheses    centres    basis    innovative    lengthy    safety    medical    tissue    feasibility    patients    die    risks    tentative    options    lacking    al    integrating    treat    prospective    pharmaceutical    market    bridge    replacement    track    cell    matrices    therapeutic    aortic    regulatory    transferring    individual    et    expertise    ethical    harmonized    accept    surgery    records    mortality    preclinical    avr    female    patient    decellularized    routine    performed    allogenic    efficacy    none    young    date    sme    translation   

Project "ARISE" data sheet

The following table provides information about the project.

Coordinator
MEDIZINISCHE HOCHSCHULE HANNOVER 

Organization address
address: Carl-Neuberg-Strasse 1
city: HANNOVER
postcode: 30625
website: www.mh-hannover.de

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 Germany [DE]
 Project website http://www.arise-clinicaltrial.eu
 Total cost 4˙954˙992 €
 EC max contribution 4˙954˙992 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-PHC-2014-single-stage
 Funding Scheme RIA
 Starting year 2015
 Duration (year-month-day) from 2015-01-01   to  2019-03-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    MEDIZINISCHE HOCHSCHULE HANNOVER DE (HANNOVER) coordinator 1˙070˙870.00
2    CORLIFE OHG DE (HANNOVER) participant 932˙813.00
3    ACADEMISCH ZIEKENHUIS LEIDEN NL (LEIDEN) participant 541˙126.00
4    ROYAL BROMPTON AND HAREFIELD NATIONAL HEALTH SERVICE TRUST UK (LONDON) participant 526˙044.00
5    CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER ES (BARCELONA) participant 486˙125.00
6    KATHOLIEKE UNIVERSITEIT LEUVEN BE (LEUVEN) participant 467˙625.00
7    GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER DE (HANNOVER) participant 401˙245.00
8    AZIENDA OSPEDALIERA DI PADOVA IT (PADOVA) participant 310˙300.00
9    UNIVERSITA DEGLI STUDI DI PADOVA IT (PADOVA) participant 218˙844.00

Map

 Project objective

65,000 aortic valve replacements (AVR) are performed in Europe each year to treat acquired and congenital aortic valve diseases. In affected patients, mortality without AVR is extremely high and 50 % die within 2 years. Current AVR options are, however, limited for young patients - especially female patients - and those unwilling to accept life-long medical anticoagulation with its inherent risks. None of the currently available prostheses for AVR is tailored toward the individual patient or allows for individual regeneration. The ARISE project will bridge this therapeutic gap in a Phase II clinical study to determine the feasibility, safety and efficacy of regenerative heart valves for aortic valve replacement.

After extensive preclinical work, Haverich et al. have used decellularized allogenic heart valve matrices for AVR on the basis of compassionate use in 34 patients with tentative assessment showing auspicious initial clinical results. However, transferring this regenerative approach to routine clinical application necessitates controlled prospective clinical trials which are lacking to date.

The translation of research in regenerative medicine from bench to bedside is frequently hampered by lengthy and complex regulatory procedures. This holds especially true for regenerative solutions based on human cell or tissue products where regulatory paths at national level are often unclear. Making these products available across Europe adds a further level of complexity as regenerative products are not subject to harmonized procedures, such as those for pharmaceutical products within Europe.

The ARISE consortium will address these challenges, integrating a network of six leading centres for cardio-thoracic surgery, each with proven track records in clinical research, an innovative SME experienced in bringing human tissue products to the clinic and market and expertise in ethical and regulatory aspects of regenerative medicine.

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 Deliverables

List of deliverables.
D.6.3 Report on the training workshop for surgeons Documents, reports 2019-05-31 12:26:42
D.2.1 Report on inaugural meeting of EGC Documents, reports 2019-05-31 12:16:08
D.2.2 Ethics and Governance Framework Documents, reports 2019-05-31 12:16:10
D.6.1 Arise public website Websites, patent fillings, videos etc. 2019-05-31 12:16:14

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

 Publications

year authors and title journal last update
List of publications.
2019 Samir Sarikouch, Karolina Theodoridis, Andres Hilfiker, Dietmar Boethig, Günther Laufer, Martin Andreas, Serghei Cebotari, Igor Tudorache, Dmitry Bobylev, Lavinia Neubert, Kristin Teiken, Jan Lukas Robertus, Danny Jonigk, Philipp Beerbaum, Axel Haverich, Alexander Horke
Early Insight Into In Vivo Recellularization of Cell-Free Allogenic Heart Valves
published pages: 581-589, ISSN: 0003-4975, DOI: 10.1016/j.athoracsur.2019.02.058
The Annals of Thoracic Surgery 108/2 2019-08-30
2017 Samir Sarikouch, Axel Haverich, John Pepper, Jose L. Pomar, Mark Hazekamp, Massimo Padalino, Giovanni Stellin, Bart Meyns, Günther Laufer, Martin Andreas, Michael Hübler, Martin Schmiady, Anatol Ciubotaru, Alexander Horke, Serghei Cebotari, Igor Tudorache
Every like is not the same
published pages: 1553-1555, ISSN: 0022-5223, DOI: 10.1016/j.jtcvs.2017.01.046
The Journal of Thoracic and Cardiovascular Surgery 153/6 2019-05-29
2018 Dmitry Bobylev, Samir Sarikouch, Igor Tudorache, Tomislav Cvitkovic, Bahar Söylen, Dietmar Boethig, Karolina Theodoridis, Harald Bertram, Philipp Beerbaum, Axel Haverich, Serghei Cebotari, Alexander Horke
Double semilunar valve replacement in complex congenital heart disease using decellularized homografts
published pages: 151-157, ISSN: 1569-9285, DOI: 10.1093/icvts/ivy212
Interactive CardioVascular and Thoracic Surgery 28/1 2019-06-06
2016 Igor Tudorache, Alexander Horke, Serghei Cebotari, Samir Sarikouch, Dietmar Boethig, Thomas Breymann, Philipp Beerbaum, Harald Bertram, Mechthild Westhoff-Bleck, Karolina Theodoridis, Dmitry Bobylev, Eduard Cheptanaru, Anatol Ciubotaru, Axel Haverich
Decellularized aortic homografts for aortic valve and aorta ascendens replacement
published pages: 89-97, ISSN: 1010-7940, DOI: 10.1093/ejcts/ezw013
European Journal of Cardio-Thoracic Surgery 50/1 2019-05-29
2015 Sarikouch, Samir; Tudorache, Igor; Cebotari, Serghei; Horke, Alexander; Haverich, Axel; Hilfiker, Andres
Aortenklappenersatz: Therapieoption für junge Patienten
published pages: A1426-A1427, ISSN: 1866-0452, DOI: 10.26068/mhhrpm/20190517-004
Deutsches Ärzteblatt 35-36 2019-05-29
2016 Samir Sarikouch, Alexander Horke, Igor Tudorache, Philipp Beerbaum, Mechthild Westhoff-Bleck, Dietmar Boethig, Oleg Repin, Liviu Maniuc, Anatol Ciubotaru, Axel Haverich, Serghei Cebotari
Decellularized fresh homografts for pulmonary valve replacement: a decade of clinical experience
published pages: 281-290, ISSN: 1010-7940, DOI: 10.1093/ejcts/ezw050
European Journal of Cardio-Thoracic Surgery 50/2 2019-05-29

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