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A novel generation of skin substitutes to clinically treat a broad spectrum of severe skin defects

Objective

Large full-thickness skin defects resulting from burns, soft tissue trauma, congenital giant nevi, tumour resection, and disease leading to skin necrosis, represent a significant and common clinical problem worldwide. This problem is far from being solved. The main challenge encountered is that most autologous skin grafting techniques are based on transplanting split-thickness skin (the today’s gold standard). Split-thickness skin contains all of the epidermis, but only remnants of the dermis. This lack of dermal tissue, frequently leads to significant scarring. Consequently, a true dermal substitute is required, which instantly exerts the cell-instructive properties of a neo-dermis. The partners of EuroSkinGraft can now offer 2 dermal substitutes, Novomaix and denovoDerm, plus the dermo-epidermal skin substitute denovoSkin. The development of all 3 substitutes was significantly supported by the FP6-program (EuroSTEC). The envisaged clinical studies are aiming strictly at a one-step surgical procedure (instead of the common two-step procedure, using Integra Artificial Skin).This is to be reached with the following protocol:
Clinical application of Novomaix
1. Experimental arm 1: split-thickness skin on Novomaix applied on full-thickness wounds
2. Reference arm 1: split-thickness skin applied directly on the wound bed
Clinical application of denovoDerm
1. Experimental arm 1: split-thickness skin on denovoDerm applied on full-thickness wounds
2. Reference arm 1: split-thickness skin applied directly on the wound bed
Clinical application of denovoSkin
1. Experimental arm 1: denovoSkin applied on full-thickness wounds
2. Reference arm 1: split-thickness skin applied directly on the wound bed
The strength of this project lies in: the high degree to which real regenerative medicine is translated into the clinic, the innovative and highly functional character of the 3 products to be tested, the central contribution of the 3 SMEs, and the excellence of the 3 clinics.

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Coordinator

University of Zurich
Address
Ramistrasse 71
8006 Zurich
Switzerland
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 3 020 144,34
Administrative Contact
Ernst Reichmann (Dr.)

Participants (9)

VERENIGING VOOR CHRISTELIJK HOGER ONDERWIJS WETENSCHAPPELIJK ONDERZOEK EN PATIENTENZORG
Netherlands
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Margreet Verweij-Deddens
VEREIN FUER BERUFSGENOSSENSCHAFTLICHE HEILBEHANDLUNG BERLIN EV
Germany
EU contribution
€ 726 060
Address
Warener Strasse 7
12683 Berlin
Activity type
Research Organisations
Administrative Contact
Dirk Stengel (Dr.)
STICHTING RADBOUD UNIVERSITEIT
Netherlands
EU contribution
€ 425 580
Address
Houtlaan 4
6525 XZ Nijmegen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Wim Van Oijen (Mr.)
MATRICEL GMBH
Germany
EU contribution
€ 302 520
Address
Kaiserstrasse 100
52134 Herzogenrath
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ingo Heschel (Dr.)
THE MEDICAL DEVICE CO LTD
United Kingdom
EU contribution
€ 402 930
Address
Kay Park Crescent 42
KA3 7BA Kilmarnock
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jeremy Francis Donnan (Mr.)
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 209 919,76
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Fuchs (Ms.)
STICHTING VUMC
Netherlands
EU contribution
€ 874 852
Address
De Boelelaan 1117
1081 HV Amsterdam
Activity type
Research Organisations
Administrative Contact
Cerdic Van Der Meulen (Mr.)
ARTTIC
France
EU contribution
€ 34 011,90
Address
Rue Du Dessous Des Berges 58A
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Martin Dietz (Dr.)
STICHTING VU

Participation ended

Netherlands
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Margreet Verweij-Deddens