ARISE SIGNED
Aortic Valve Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap
Total Cost €
0EC-Contrib. €
0Partnership
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Project "ARISE" data sheet
The following table provides information about the project.
| Coordinator |
MEDIZINISCHE HOCHSCHULE HANNOVER
Organization address contact info |
| 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.
| # | ||||
|---|---|---|---|---|
| 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
| 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 |
|---|---|---|---|
| 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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