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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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Outcomes and
results

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.

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

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 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.	DE (HANNOVER)	coordinator	1˙070˙870.00
2	CORLIFE OHG CORLIFE OHG Organization address address: FEODOR LYNEN STRASSE 23 city: HANNOVER postcode: 30625 website: www.corlife.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HANNOVER)	participant	932˙813.00
3	ACADEMISCH ZIEKENHUIS LEIDEN ACADEMISCH ZIEKENHUIS LEIDEN Organization address address: ALBINUSDREEF 2 city: LEIDEN postcode: 2333 ZA website: www.lumc.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (LEIDEN)	participant	541˙126.00
4	ROYAL BROMPTON AND HAREFIELD NATIONAL HEALTH SERVICE TRUST ROYAL BROMPTON AND HAREFIELD NATIONAL HEALTH SERVICE TRUST Organization address address: SYDNEY STREET city: LONDON postcode: SW3 6NP website: www.rbht.nhs.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	526˙044.00
5	CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER Organization address address: CALLE ROSSELLO 149 PUERTA BJS city: BARCELONA postcode: 8036 website: http://www.idibaps.org/en_index.html contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (BARCELONA)	participant	486˙125.00
6	KATHOLIEKE UNIVERSITEIT LEUVEN KATHOLIEKE UNIVERSITEIT LEUVEN Organization address address: OUDE MARKT 13 city: LEUVEN postcode: 3000 website: www.kuleuven.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (LEUVEN)	participant	467˙625.00
7	GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER Organization address address: Welfengarten 1 city: HANNOVER postcode: 30167 website: www.uni-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.	DE (HANNOVER)	participant	401˙245.00
8	AZIENDA OSPEDALIERA DI PADOVA AZIENDA OSPEDALIERA DI PADOVA Organization address address: VIA GIUSTINIANI 1 city: PADOVA postcode: 35128 website: www.sanita.padova.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (PADOVA)	participant	310˙300.00
9	UNIVERSITA DEGLI STUDI DI PADOVA UNIVERSITA DEGLI STUDI DI PADOVA Organization address address: VIA 8 FEBBRAIO 2 city: PADOVA postcode: 35122 website: www.unipd.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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

List of publications.
year	authors and title	journal	last update
2019	Samir Sarikouch, Karolina Theodoridis, Andres Hilfiker, Dietmar Boethig, GÃ¼nther 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 InÂ 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, GÃ¼nther Laufer, Martin Andreas, Michael HÃ¼bler, 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 SÃ¶ylen, 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 fÃ¼r junge Patienten published pages: A1426-A1427, ISSN: 1866-0452, DOI: 10.26068/mhhrpm/20190517-004	Deutsches Ã„rzteblatt 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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The information about "ARISE" are provided by the European Opendata Portal: CORDIS opendata.

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