Engineered skin for critical wounds

An innovative system for reconstructing skin may avoid foot amputation for many diabetics and provide better treatment for patients suffering from severe burns and chronic ulcers.

Keywords: biomaterials, skin grafts, skin reconstruction, burns, ulcers

Background

In Europe each year, some 60,000 diabetics undergo amputation because of foot ulcers. Over 20,000 people suffer disfiguring to life-threatening burns. Chronic venous ulcers affect over 0.5% of the population. The Brite-EuRam project ‘Development of a Biodegradable Scaffold for Dermo-Epidermal Skin Grafts’ aims to provide improved, cost-effective treatment for these patients in the form of a biodegradable scaffold seeded with the patient’s own cells and supporting skin reconstruction at the wound site.

Description, impact and results

The idea is to combine fibroblasts (dermal cells) and keratinocytes (epidermal cells) in a scaffold made from a hyaluronic acid derivative, a molecule naturally present in skin. The device would consist of a thin top membrane (for the keratinocytes) and an underlying sponge-like layer (for the fibroblasts). Designed to favour growth and joining of the two skin layers, the scaffold would be biodegraded in time with the healing process. So far two first-generation systems have been developed and patented, one for dermal and one for epidermal reconstruction.

Currently on sale in Italy, they use the patient’s own cells, derived from a small biopsy and expanded in culture. The only comparable systems, sold only in the US, use cells taken from donors. Donor cells can provide growth factors to stimulate healing but, as has been shown in this project, they cannot survive and integrate. Several clinical tests are in progress – over 1000 patients have been treated with the scaffolds to date. Hopes are high that the system will promote better healing of problematic wounds and make burn treatment less disfiguring. The aim now is to enable delivery of both cell types in a single step. There are plans for duplicating, in at least four countries, the entity that provides the scaffolds (this would create some 250 high-quality jobs). The findings are also being applied to other tissues (tendon, bone, cartilage, adipose tissue) in the framework of new projects. With this work, Europe has gained a footing in a field previously dominated by the US. At the major conference ‘Tissue Repair, Replacement, and Regeneration’ (New York, October 1999), only three of the 60 participants were European – a partner in this project was one of them.

Working partnerships

Fidia Advanced Biopolymers (Italy) produces the polymers and scaffolds and will exploit the technology. The Italian Centro Nazionale per la Ricerca e lo Sviluppo dei Materiali (PASTIS-CNRSM) tests the degradation and mechanical properties of the scaffolds. The German Deutsches Krebsforschungszentrum (DKFZ) studies interactions between the cells and biomaterials in vitro and in rodents, while Belgian Houget Duesberg Bosson (HDB) performs does the scaling-up of the scaffold production technology. Rheinische-Westfälische Technische Hochshule (RWTH, Germany) carries out tests in a rat model and the London team, St. Bartholomews & the Royal London School of Medicine and Dentistry & Queen Mary & Westfield College (LHMC) carries out tests in large animal models. Both clinical teams (London and the RWTH) are responsible for the pilot scale clinical tests.

Project information at the European Commission

Project title: Development of a Biodegradable Scaffold for Dermo-Epidermal Skin Grafts

Project reference: BRPR960227

Information on the Fifth Framework Programme:

http://europa.eu.int/comm/dg12/fp5.html

http://www.cordis.lu/fp5/

Contact: Dr Uta Faure

Research DG - Directorate C2 - Materials and Steel

Unit C2: Materials and Steel

Tel: +32-2-29 63 334

Fax: +32 2 29 65 987

E-mail: Uta.Faure@.cec.eu.int

Contacts/Partners

Coordinator (Country):

Fidia Advanced Polymers

Scientific Coordinator: Dr Alessandra Pavesio

Tel: +39 0 49 82 32 888 - Fax: +39 0 49 82 32 752

E-mail: apavesio.fab@protec.it

Project management, technical coordination, and exploitation: Dr Claudio de Luca

Tel: +39 0 49 82 32 314 - Fax: +39 0 49 82 32 752

E-mail:rdfab@protec.it

Centro Nazionale per la Ricerca e lo Sviluppo dei Materiali (PASTIS-CNRSM)

Contact: Dr Eva Milella

Tel: +39 0 831 507 263 - Fax: +39 0 831 507 361

E-mail: milella@popserver.cnrsm.it

Belgium:

Houget Duesberg Bosson (HDB)

Contact: Dr André Theys

Tel: +32 87 393 211 - Fax: +32 87 316 629

E-mail: hdb.1823@skynet.be

Rheinische-Westfälische Technische Hochshule (RWTH)

Contact: Dr Bernd Hafemann and Dr Dennis Von Heimburg

Tel: +49 241 80 89 742- Fax: +49 241 88 88 448

E-mail: D.v.Heimburg@plastchir.rwth-aachen.de

United Kingdom:

St. Bartholomews & the Royal London School of Medicine and Dentistry & Queen Mary & Westfield College (LHMC)

Contact: Prof Irene Leigh

Tel: +44 171 295-7170 - Fax: +44 171 295-7171

E-mail: I. Leigh@ircf.icnet.uk

Contact: Dr Harry Navsaria

Tel: +44 171 295 7163 - Fax: +44 171 295 7171

E-mail :h.navsaria@ircf.icnet.uk

Germany:

Deutsches Krebsforschungszentrum (DKFZ)

Contact: Dr Norbert Robert E. Fusenig

Tel: +49 6221 42 4507- Fax: +49 6221 42 4551

E-mail: N.Fusenig@DKFZ-Heidelberg.de

Other information

Publications:

        “Semi-synthetic resorbable materials from hyaluronan esterification” (1998). Biomaterials 19, 2101-2127;

        “Auto cross-linked polysaccharide: properties of sponge obtained by the crosslinking of hyaluronic acid”. 15^th European Conference on Biomaterials, Bordeaux, September 1999;

        “Do allogeneic fibroblasts survive transplantation?”. European Tissue Repair Society Meeting, Bordeaux, August 1999;

        “Use of hyaluronic acid and cultured autologous keratinocytes and fibroblasts in extensive burns” (1999). The Lancet, 353 n°9146, 35-36.

Photographs:

        For photographs, contact the scientific coordinator

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