Fidia Advanced Biopolymers

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Santoro R.,University of Basel | Olivares A.L.,Institute for Bioengineering of Catalonia | Brans G.,Applikon Biotechnology BV | Wirz D.,University of Basel | And 4 more authors.
Biomaterials | Year: 2010

Apart from partial or total joint replacement, no surgical procedure is currently available to treat large and deep cartilage defects associated with advanced diseases such as osteoarthritis. In this work, we developed a perfusion bioreactor system to engineer human cartilage grafts in a size with clinical relevance for unicompartmental resurfacing of human knee joints (50 mm diameter × 3 mm thick). Computational fluid dynamics models were developed to optimize the flow profile when designing the perfusion chamber. Using the developed system, human chondrocytes could be seeded throughout large 50 mm diameter scaffolds with a uniform distribution. Following two weeks culture, tissues grown in the bioreactor were viable and homogeneously cartilaginous, with biomechanical properties approaching those of native cartilage. In contrast, tissues generated by conventional manual production procedures were highly inhomogeneous and contained large necrotic regions. The unprecedented engineering of human cartilage tissues in this large-scale opens the practical perspective of grafting functional biological substitutes for the clinical treatment for extensive cartilage defects, possibly in combination with surgical or pharmacological therapies to support durability of the implant. Ongoing efforts are aimed at integrating the up-scaled bioreactor based processes within a fully automated and closed manufacturing system for safe, standardized, and GMP compliant production of large-scale cartilage grafts. © 2010 Elsevier Ltd.


Miot S.,University of Basel | Brehm W.,University of Bern | Brehm W.,University of Leipzig | Dickinson S.,University of Bristol | And 6 more authors.
European Cells and Materials | Year: 2012

This study was designed to determine if the maturation stage of engineered cartilage implanted in a goat model of cartilage injury influences the repair outcome. Goat engineered cartilage was generated from autologous chondrocytes cultured in hyaluronic acid scaffolds using 2 d, 2 weeks or 6 weeks of pre-culture and implanted above hydroxyapatite/hyaluronic acid sponges into osteochondral defects. Control defects were left untreated or treated with cell-free scaffolds. The quality of repair tissues was assessed 8 weeks or 8 months post implantation by histological staining, modified O'Driscoll scoring and biochemical analyses. Increasing pre-culture time resulted in progressive maturation of the grafts in vitro. After 8 weeks in vivo, the quality of the repair was not improved by any treatment. After 8 months, O'Driscoll histology scores indicated poor cartilage architecture for untreated (29.7 ± 1.6) and cell-free treated groups (24.3 ± 5.8). The histology score was improved when cellular grafts were implanted, with best scores observed for grafts pre-cultured for 2 weeks (16.3 ± 5.8). As compared to shorter pre-culture times, grafts cultured for 6 weeks (histology score: 22.3 ± 6.4) displayed highest type II/I collagen ratios but also inferior architecture of the surface and within the defect, as well as lower integration with native cartilage. Thus, pre-culture of engineered cartilage for 2 weeks achieved a suitable compromise between tissue maturity and structural/integrative properties of the repair tissue. The data demonstrate that the stage of development of engineered cartilage is an important parameter to be considered in designing cartilage repair strategies.


Cencetti C.,University of Rome La Sapienza | Bellini D.,Fidia Advanced Biopolymers | Longinotti C.,Fidia Advanced Biopolymers | Martinelli A.,University of Rome La Sapienza | Matricardi P.,University of Rome La Sapienza
Journal of Materials Science: Materials in Medicine | Year: 2011

Postsurgical adhesions are a common problem in clinical practice, causing nerve compression, pain and discomfort. A new hydrogel based on gellan gum and sulphated hyaluronic acid was synthesized, with the aim to create an effective barrier for epidural scar formation. Physico-chemical properties of the gel were analyzed, and preliminary biocompatibility data (i.e. cytotoxicity) have been collected in view of its potential clinical use. The characterization of the new material demonstrated that the hydrogel, due to its high-viscosity, could effectively act as a barrier with a long in situ residence time. In addition, the hydrogel can be easily extruded from a syringe and its structure exhibits excellent stabilizing properties. Furthermore, biological assays showed that this gel is suitable for further preclinical development. © 2010 Springer Science+Business Media, LLC.


Rhodes N.P.,University of Liverpool | Hunt J.A.,University of Liverpool | Longinotti C.,Fidia Advanced Biopolymers | Pavesio A.,Fidia Advanced Biopolymers
Journal of Surgical Research | Year: 2011

Background: Musculoskeletal reconstructive surgery often requires removal of significant quantities of bone tissue, such as the periosteum, causing critical problems following surgery like friction between different tissues and adhesion of soft tissues to the underlying bone. We studied the long-term host response and closure of large bone defects for periosteal reconstruction using Hyalonect, a novel membrane comprising knitted fibers of esterified hyaluronan, (HYAFF11). Materials and Methods: For biological characterization, 162 rats were used in a defect model in which a section of the dorsal muscular fascia was removed, and the membrane behavior observed over 540 d using conventional histology, with sham operated rats as controls. In addition, Hyalonect was used to cover defects made in the humeri of 7 dogs, filled with a variety of conventional bone filling compounds, and the regeneration process observed after 6 wks using histology. Results: Low levels of inflammation were observed in the dorsal muscle fascia defect model, with cellular colonization of the mesh by 30 d, vascularization by 120 days, matrix fiber organization by 270 d, and the appearance of connective tissue identical to the surrounding tissue between 365 and 540 d, without the formation of fibrotic tissue. In addition, Hyalonect was shown to allow the regeneration of bone within the humeral defects whilst preventing fibrotic tissue in-growth, and allowing regeneration of tissue which, by 6 wk, had begun to resemble natural periosteal tissue. Conclusion: Hyalonect is suitable for improving the outcome of the final phases of orthopedic and trauma reconstructive surgical procedures, especially in the reconstruction of periosteal tissue.


Patent
Genetics Institute LLC and Fidia Advanced Biopolymers | Date: 2011-02-23

The present invention relates to a use of a composition for injectable delivery of osteogenic proteins comprising a pharmaceutically acceptable admixture comprising an osteogenic protein and injectable hyaluronic acid esters solubilized in organic solvent or aqueous buffer for preparation of a medicament for injectable treatment of damaged bone or tissue in a patient.


Fidia Advanced Biopolymers | Entity website

Fidia farmaceutici s.p ...


Fidia Advanced Biopolymers | Entity website

P&R Holding was established in 2006 and includes several companies operating in different business sectors. The Group is mainly involved in the R&D, manufacturing, marketing and sales of finished dosage forms and APIs for the pharmaceutical industry ...


Fidia Advanced Biopolymers | Entity website

Fidia Farmaceutici S.p ...


Fidia Advanced Biopolymers | Entity website

Key Business AreasFidia operates in numerous therapeutic areas, providing specific, innovative treatments for commonly occurring pathologies with major socio-economic impact, namely: - joint healthcare - advanced wound care - dermatology - neurology - dermo-aesthetics

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