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Hybrid bio-artificial ligament and tendon reconstruction devices prepared by combining synthetic and natural materials with tissue engineering techniques

Objective



Objectives and content: Ligament and tendon surgery is a fast growing operative treatment due to the increased occurrence of sport accident injuries. The most widely used reconstruction method is currently the substitution of the injured tendon/ligament with autologous tissue. Nevertheless, the drawbacks of this painful therapy are the initial low strength, the high probability of rupture during the early post repair phase, the long recovery period, the low availability of suitable material to harvest and creation of a new injury at the harvest site. Artificial prostheses should indeed provide a good solution for tendon or ligament reconstruction, as they can be manufactured in any required size, be ready to use and reduce operating time. All the prostheses, which are nowadays commercially available (generally consisting of alloplastic material) however, have shown low reliability mainly in terms of wear but also in terms of strength, elasticity, and biocompatibility (i.e. chronic syovitis).

Therefore, the high failure rate of the "first generation" synthetic ligaments and tendons and the drawbacks of the autologous transplant open the need for new and effective solutions. On these premises, the objective of the project is to develop a completely novel hybrid bioartificial ligament and tendon prostheses able to adequately emulate the complex structure-&-function of the natural tissues and consistently improve the success rate and avoid the side effects of the currently available treatment. The strategy hereby proposed for the development of these new reconstruction devices is that to imitate the composite structure of the natural tendon/ligament as closely as possible. Natural tendons and ligaments are highly complex structures, constituted by a protein phase (i.e. collagen and elastin), a polysaccharide phase (i.e. proteoglycans) and a cellular phase. A good reproduction of the mechanical and biological features of the natural tendon/ligament is hence impossible to obtain with a single alloplastic material.

The industrial aim of the project is therefore to develop device-engineering technologies by combining:
- knitting, braiding and filament winding technologies;
- technologies for modification of surfaces;
- tissue engineering technologies thus producing biocompatible and bioresorbable hybrid bio-artificial tendon and ligament reconstruction devices which combine the advantages of the autograft technique without the delay of healing and the morbidity of donor site correlated with this approach. On the other hand this approach should overcome the limitations of the pure synthetic devices.

The composite devices will thus consist of:
- HYAFF fibres (i.e. new bio-interactive Hyaluronic Acid-based polymers);
- PolyLacticAcid fibres;
- Hyaluronic Acid based matrix or coating (to guide cell attachment and in growth);
- precursors of tendon/ligament cells. The biological and biomechanical properties of the devices will be carefully investigated in vitro and in small and large animal models and should be comparable with the original host structure.

An interactive loop device engineering-physico-mechanical characterisation-biological testing-device engineering will be balanced to ensure a progressive contribution to finer modifications of the device's attributes. BE97-5063

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

FIDIA ADVANCED BIOPOLYMERS SRL
Address
Via Ponte Della Fabbrica 3/B
35031 Abano Terme
Italy

Participants (5)

BIOMATECH S.A.
France
Address
Rue Pasteur 115, Z.i. L'islon
38670 Chasse Sur Rhone
Sofradim Production S.A.
France
Address
197,Avenue Théodore Braun
69400 Villefranche Sur Saône
THE UNIVERSITY OF LIVERPOOL
United Kingdom
Address
Daulby Street Royal Liverpool University Hospital
L69 3GA Liverpool
Universitá degli Studi di Napoli Federico II
Italy
Address
Via Costantinopoli
80138 Napoli
Universität Ulm
Germany
Address
14,Hemlholtzstrasse
89081 Ulm