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

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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Field of science

  • /social sciences/economics and business/business and management/commerce
  • /medical and health sciences/clinical medicine/surgery
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /social sciences/sociology/demography/mortality

Call for proposal

H2020-PHC-2014-single-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

MEDIZINISCHE HOCHSCHULE HANNOVER
Address
Carl-neuberg-strasse 1
30625 Hannover
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 070 870

Participants (8)

CORLIFE OHG
Germany
EU contribution
€ 932 813
Address
Feodor Lynen Strasse 23
30625 Hannover
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ROYAL BROMPTON AND HAREFIELD NATIONAL HEALTH SERVICE TRUST
United Kingdom
EU contribution
€ 526 044
Address
Sydney Street
SW3 6NP London
Activity type
Higher or Secondary Education Establishments
CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER
Spain
EU contribution
€ 486 125
Address
Calle Rossello 149 Puerta Bjs
08036 Barcelona
Activity type
Other
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 541 126
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DEGLI STUDI DI PADOVA
Italy
EU contribution
€ 218 844
Address
Via 8 Febbraio 2
35122 Padova
Activity type
Higher or Secondary Education Establishments
AZIENDA OSPEDALE UNIVERSITA PADOVA
Italy
EU contribution
€ 310 300
Address
Via Nicolo Giustiniani 1
35128 Padova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 467 625
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER
Germany
EU contribution
€ 401 245
Address
Welfengarten 1
30167 Hannover
Activity type
Higher or Secondary Education Establishments