Publications

Follow the technical history of IBI products and keep yourself updated on new results.

Applications of Bioresorbable Polymers in the skeletal systems (cartilages, tendons, bones) Applications of Bioresorbable Polymers in the skeletal systems (cartilages, tendons, bones)
Date:2016
Journal:Bioresorbable Polymers for Biomedical Applications - Pages 391-422 Woodhead Publishing Series in Biomaterials: Number 120 Edited by Giuseppe Perale and Jons Hilborn
Authors:

E.C. Ekwueme, J.M. Patel, J.W. Freeman, S. Danti

Abstract

The skeletal system provides structure, protection, and movement to the body through bones, cartilages, tendons, and ligaments. Many congenital, traumatic, and degenerative diseases may affect the function of skeletal tissues during the life span, leading to the necessity of very specific replacements and treatments. In the widespread and mechanically constraining scenario of skeletal pathologies, biodegradable polymers can play unique roles that should not only be confined to adjuvant bulk devices. Tissue engineering has recently renewed the attention towards this class of biomaterials, enchantingly exploiting their outstanding versatility to accomplish smart and biomimetic solutions to surgical and therapeutic needs. This chapter describes the most recent achievements in this field, focusing on tissue type- and subtype-specific replacements, while taking into account clinical applications and future trends.

 

Positioning of a Contextual Implant Along with a Sinus Lift with Smartbone® Microchips of Composite Heterologous-Synthetic Bone Positioning of a Contextual Implant Along with a Sinus Lift with Smartbone® Microchips of Composite Heterologous-Synthetic Bone
Date:2016
Journal:Indian Journal Stomatology 2015/Volume 6/Issue 2
Authors:

Ilaria Zollino, Giorgio Carusi, Francesco Carinci, Giuseppe Perale

Abstract

The present case reports the success rate after 8 months of follow-up in a sinus pneumatization case with maxillary sinus floor cortical bone loss due to 2.5 dental agenesis. Rehabilitation including the opportunity to insert a contextual implant during maxillary sinus lift surgery was planned, using SmartBone® Microchips heterologous bone inserted into the maxillary sinus. The newly developed bone substitute was designed starting from bovine bone derived mineral matrix, reinforced with bioresorbable aliphatic polymers and cell nutrients. SmartBone® Microchips showed a tight contact with the new bone and neither gaps nor fibrous tissues at the interface. No inflammation or foreign body reaction were observed, and these findings support the good biocompatibility of SmartBone® Microchips composite material. Moreover, new bone, thanks to its mechanical properties, consented to fix screw in combination with maxillary sinus floor elevation for a dental implant.

Conclusion

The newly developed bone substitute SmartBone® Microchips showed in a patient with jaw cortical pavement defect a tight contact with the new bone and neither gaps nor fibrous tissues at the interface. No inflammation or foreign body reaction were observed, and these findings support the good biocompatibility of SmartBone® Microchips composite material. Moreover, new bone, thanks to its mechanical properties, consented to fix one screw in combination with maxillary sinus floor elevation for the dental implant. All these statements showed the good suitability of SmartBone® Microchips for alveolar defect repair in sinus lift procedure

Bone matrix/copolymer/gelatin scaffold (SmartBone®) as a biomimetic graft for sinus lift procedure in dental surgery Bone matrix/copolymer/gelatin scaffold (SmartBone®) as a biomimetic graft for sinus lift procedure in dental surgery
Date:2016
Journal:10th World Biomaterials Congress, Montréal, Canada, 17 May - 22 May, 2016.
Authors:

M. Milazzo, D. D’Alessandro, S. Danti, C. Stefanini, G. Pertici, nd G. Perale

Abstract

The ideal scaffold for bone regeneration needs a number of requirements, such as biostability until the formation of mature tissue, high porosity for cell migration, extracellular matrix (ECM) deposition and vascularization, and non-immunogenicity. Moreover it should be bioresorbable, osteoconductive and possibly osteoinductive. Processed bovine spongy bone xenografts, coated with poly(L-lactic-co-ε-caprolactone) (PLCL) and added with gelatin are commercially available as a new class III medical device (SmartBone®, IBI S/A, Switzerland) [1]. This study was aimed at investigating the process of new bone formation in patients treated with SmartBone® for sinus lift procedures prior to dental implants.

Reinforced bioactive bone chip scaffold for bone regeneration: experimental study Reinforced bioactive bone chip scaffold for bone regeneration: experimental study
Date:2015
Journal:Dental Materials 3 0 S ( 2 0 1 4 ) e1–e180
Authors:

L. Laffranchi, B. Buffoli, R. Boninsegna, F. Zotti, F. Savoldi, P. Fontana, S. Bonetti, L. Visconti, L.F. Rodella, C. Paganelli

Abstract

Purpose: Scaffolds play a critical role in tissue engineering, which aims to regenerate missing tissues or organs. For developing an effective bone regeneration strategy, we studied the efficacy of bone regeneration using the innovative bone scaffold “Reinforced Bioactive Bone Chip” (IBI SA-Mezzovico, Ticino-CH), which has been specifically developed for applications in regenerative medicine and therapy bone tissue engineering, on the calvarial defect of rats.

Methods and materials: A full-thickness defect (5mm×8mm) was created on each parietal region of Wistar rats (Harlan, Italy) by piezosurgery, a surgical technique that creates an effective osteotomy with no trauma to soft tissue and without causing bone necrosis. Bone scaffold was implanted in the right cranial defect whereas the left defect was used as control. Macroscopical evaluation of the surgical site and histological studies were performed to investigate the level of bone formation.

Results: The results confirmed that the treated defects with “Reinforced Bioactive Bone Chip” scaffold showed significant bone formation and maturation in comparison with the control group.

Conclusion: These results are promising and “Reinforced Bioactive Bone Chip” could be considered for future clinical use in human, mainly in the field of regeneration and/or replacement of bone tissue compartment of maxillofacial surgery.

Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies
Date:2015
Journal:
Authors:

G. Pertici, G. Perale

Abstract

Bovine bone xenografts, made of hydroxyapatite (HA), were coated with poly(L-lactide-co-ε-caprolactone) (PLCL) and RGD-containing collagen fragments in order to increase mechanical properties, hydrophilicity, cell adhesion and osteogenicity. In vitro the scaffold microstructure was investigated with Environmental Scanning Electronic Microscopy (ESEM) analysis and micro tomography, while mechanical properties were investigated by means compression tests. In addition, cell attachment and growth within the three-dimensional scaffold inner structure were validated using human osteosarcoma cell lines (SAOS-2 and MG-63). Standard ISO in vivo biocompatibility studies were carried out on model animals, while bone regenerations in humans were performed to assess the efficacy of the product. All results from in vitro to in vivo investigations are here reported, underlining that this scaffold promotes bone regeneration and has good clinical outcome.

Reconstruction of the zygomatic bone with SmartBone®: Case Report Reconstruction of the zygomatic bone with SmartBone®: Case Report
Date:2015
Journal:Journal of biological regulators & homeostatic agents - Vol. 29, no. 3 (S1), 42-47 (2015)
Authors:

Grecchi F, Perale G, Candotto V, Busato A, Pascali M, Carinci F

Abstract

The repair of complex craniofacial bone defects is challenging and a successful result depends on the defect size, the quality of the soft tissue covering the defect and the choice of reconstructive method. Autologous bone grafts are the gold standard for bone replacement. Tissue engineered constructs are temporary substitutes developed to treat damaged or lost tissue. Recent advances in materials science have provided an abundance of innovations, underlining the increasing importance of polymer in this field. The Galeazzi Orthopedical institute of Milan received a Serbian soldier who reported a deep wound, due to the explosion of a grenade, during former-Yugoslavia’s war. His left cheekbone was completely lost, together with the floor of the left eye. SmartBone® technology allowed the realization of custom-made grafts which perfectly fitted the bone defect thanks to mechanical strength, also at small thicknesses, and the ability to be shaped without powder formation or unpredicted fractures. Tissue engineering approaches to regeneration utilize 3-dimensional (3D) biomaterial matrices that interact favorably with cells. The potential benefits of using a tissue engineering approach include reduced donor site morbidity, shortened operative time, decreased technical difficulty of the repair, ability to closely mimic the in vivo microenvironment in an attempt to recapitulate normal craniofacial development: this 36-month case study allowed to prove that SmartBone® custom-made bone grafts are an effective solution, gathering such benefits and being available now for daily routine.

Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies Composite polymer-coated mineral scaffolds for bone regeneration: from material characterization to human studies
Date:2015
Journal:Journal of biological regulators & homeostatic agents - Vol. 29, no. 3 (S1), 136-148 (2015)
Authors:

Pertici G , Carinci F , Carusi G , Epistatus D , Villa T , Crivelli F , Rossi F , Perale G

Abstract

Bovine bone xenografts, made of hydroxyapatite (HA), were coated with poly(L-lactide-co-ε-caprolactone) (PLCL) and RGD-containing collagen fragments in order to increase mechanical properties, hydrophilicity, cell adhesion and osteogenicity. In vitro the scaffold microstructure was investigated with Environmental Scanning Electronic Microscopy (ESEM) analysis and micro tomography, while mechanical properties were investigated by means compression tests. In addition, cell attachment and growth within the three-dimensional scaffold inner structure were validated using human osteosarcoma cell lines (SAOS-2 and MG-63). Standard ISO in vivo biocompatibility studies were carried out on model animals, while bone regenerations in humans were performed to assess the efficacy of the product. All results from in vitro to in vivo investigations are here reported, underlining that this scaffold promotes bone regeneration and has good clinical outcome.

SmartBone®on Demand™ applied to a post humoral large spheno-orbital reconstruction SmartBone®on Demand™ applied to a post humoral large spheno-orbital reconstruction
Date:2014
Journal:
Authors:

Abstract

After almost two years of positive clinical feedback, in November 2013, the innovative bone substitute SmartBone® made it possible to successfully engage in a great maxillo facial surgical challenge. Thanks to a profitable collaboration between the Swiss biomedical company Industrie Biomediche Insubri SA and the renowned University of Modena a complex large sphenoid orbital reconstruction case was accomplished using a revolutionary approach. The outstanding biomechanical and microstructural properties of SmartBone®, that in these last two years obtained great results in the dental field and in reconstructive surgery, have allowed the surgeons of the University of Modena to treat the case with excellency and promising results.

 

 

Composite polymer-coated mineral grafts for bone regeneration: material characterisation and model study Composite polymer-coated mineral grafts for bone regeneration: material characterisation and model study
Date:2014
Journal:Annals of Oral & Maxillofacial Surgery 2014 Feb 14;2(1):4
Authors:

G Pertici, F Rossi, T Casalini, G Perale

Abstract

Introduction

This study discusses composite polymer-coated mineral grafts for bone regeneration.

Materials and Methods

Bone xenografts are coated with degradable synthetic [poly(L-lactide-co-e-caprolactone)] and natural (polysaccharides) polymers in order to increase their mechanical properties, on one side, and to improve cell adhesion, on the other, with the purpose of developing a novel composite material for bone tissue engineering. In vitro assays help examine the microstructure of the scaffold by Fourier transform infrared and environmental scanning electron microscopy analyses and the porosity of the material by micro-computed tomography. The good adhesion property of polymer coated on to the mineral scaffold is deeply analysed and proved. The in vitro polymer degradation, in terms of time evolution of polymer-coating thickness, was rationalised with a mathematical model. The purpose of such modelling activity is to provide a simple but powerful tool to understand the influence of design parameters on coating behaviour.

Results

The fabricated bone graft exhibited regular microstructure similar to healthy iliac bones with an average of 27% open porosity and an adequately rigid structure, which ensures a better osteointegration once implanted.

Conclusion

This approach avoids the use of trialand-error methods and consents a better a priori material design.

Custom-made bone grafts for reconstructive maxillo-facial surgery: a case study Custom-made bone grafts for reconstructive maxillo-facial surgery: a case study
Date:2013
Journal:European Cells and Materials Vol. 26. Suppl. 2, 2013; Scandinavian society for biomaterials annual meeting Upsala
Authors:

G. Pertici, F. Grecchi, G. Perale

Abstract

Scaffolds for bone regeneration should ensure both mechanical stability and strength. Moreover, their intimate structure should have an adequate interconnected porous network for cell migration and proliferation, while also providing specific signals for bone regeneration. SmartBone® composite solution, based on a novel concept of biomaterial assembly, bearing cues from both mineral components and polymeric ones [1-3], was chosen to develop new patient-specific three-dimensional bone grafts. Indeed, thanks to mechanical performances and to full control over production, custom-made bone grafts can be produced according to the specific need of each single patient, via digital surgical planning, starting from CT scans.

http://www.ecmjournal.org

 

Polymeric scaffolds as stem cell carriers in bone repair Polymeric scaffolds as stem cell carriers in bone repair
Date:2013
Journal:Journal of Tissue Engineering and Regenerative Medicine (J Tissue Eng Regen Med)
Authors:

Filippo Rossi, Marco Santoro, Giuseppe Perale

Abstract

Although bone has a high potential to regenerate itself after damage and injury, the efficacious repair
of large bone defects resulting from resection, trauma or non-union fractures still requires the
implantation of bone grafts. Materials science, in conjunction with biotechnology, can satisfy these
needs by developing artificial bones, synthetic substitutes and organ implants. In particular, recent
advances in polymer science have provided several innovations, underlying the increasing importance
of macromolecules in this field. To address the increasing need for improved bone substitutes,
tissue engineering seeks to create synthetic, three-dimensional scaffolds made from polymeric materials,
incorporating stem cells and growth factors, to induce new bone tissue formation. Polymeric
materials have shown a great affinity for cell transplantation and differentiation and, moreover, their
structure can be tuned in order to maintain an adequate mechanical resistance and contemporarily
be fully bioresorbable. This review emphasizes recent progress in polymer science that allows relaible
polymeric scaffolds to be synthesized for stem cell growth in bone regeneration. Copyright © 2013
John Wiley & Sons, Ltd.

SmartBone®: a new scaffold for regenerative medicine SmartBone®: a new scaffold for regenerative medicine
Date:2012
Journal:1st International Conference on Design and PROcesses for MEdical Devices - PROMED 2012 - 2-4 May, Padenghe sul Garda – Brescia (Italy)
Authors:

G. Pertici, M. Müller, F. Rossi, T. Villa, G. Carusi, S. Maccagnan, F. Carù, F. Crivelli, G. Perale

Abstract

Scaffolds for bone tissue engineering should ensure both mechanical stability and strength. Moreover, their intimate structure should have an adequate interconnected porous network for cell migration and proliferation, while also providing specific signals for bone regeneration.

A composite solution, based on a novel concept of biomaterial assembly, bearing cues from both mineral components and polymeric ones, was here followed to develop a new three-dimensional bone scaffold. A bovine derived mineral matrix was used to provide adequate 3D structure and porosity, while a resorbable biopolymer was used to reinforce it. Bioactive agents were added to promote cell adhesion and proliferation.

Microstructure was evaluated by E/SEM and micro-CT, confirming a strong resemblance with human cortical bone in terms of open mid-sized porosity. Compression tests evidenced a maximum stress capability (20MPa av.) three times higher than best available bovine derived bone, with a four-fold improved Young’s modulus (0.2GPa av.).

Overall mechanical behaviour was typical of open cellular structures: a first pseudo-linear and pseudo-elastic behaviour, due to structural resistance, was followed by oscillating behaviour due to progressive breakage of structure and consequent matrix compacting. Moreover, it resulted feasible for reconstructive surgery, being both easy to shape and resistant to screws and fixation manoeuvres.

Citocompatibility and cell viability were positively assessed in vitro with standard SAOS-2 and MG-63 line cells. Human adipose tissue derived mesenchymal stem cells were also tested and data showed in vitro capability to properly colonize the scaffold and, once induced, to differentiate.

Tibial grafts on adult white New Zealand rabbits were performed to assess in vivo osteointegration during 4 months observations. Histological analysis proved confirmation of matrix integration with natural bone and showed cells and vessels colonizing pores within it during time.

Data collected represent a complete proof of concept for this new scaffold and its application for bone tissue regeneration.

Microextrusion as a way for combining performance, functions and quality Microextrusion as a way for combining performance, functions and quality
Date:2012
Journal:1st International Conference on Design and PROcesses for MEdical Devices - PROMED 2012 - 2-4 May, Padenghe sul Garda – Brescia (Italy)
Authors:

S. Maccagnan, G. Perale, T. Cappelletti, G. Pertici

Abstract

Polymer processing is at the days of the more challenging evolutions of the medical device industry. The reason of that is strongly related to the molecular characteristics of the polymer, which are able to induce unique properties in the device and in each of its components. It is obvious that if the raw material gets spoiled during the process it will differ from the expected properties in a way that will be proportional to the level of complexity of the macromolecules.
Microexrtusion is a kind of process which allows not simply to preserve such properties, but also to combine several polymers with different properties in the same volume inducing different features on the base of the relative position within the device.

SmartBone® On Demand™: an innovative custom-made bone graft for reconstructive surgery SmartBone® On Demand™: an innovative custom-made bone graft for reconstructive surgery
Date:2012
Journal:1st International Conference on Design and PROcesses for MEdical Devices - PROMED 2012 - 2-4 May, Padenghe sul Garda – Brescia (Italy)
Authors:

G. Perale, G. Pertici, A. Motroni, L. Livi, A. Busato, F. Grecchi

Abstract

Industrie Biomediche Insubri SA (IBI) developed new technologies to improve the properties of natural materials for biomedical applications: indeed, IBI produces Smartbone®, a bone substitute specifically developed for orthopaedic reconstructive surgery. This innovative scaffold has a composite structure based on a bovine derived bone matrix reinforced with biodegradable polymers and bioactive agents.

The bovine derived matrix allows maintaining an adequate 3D-structure, with an open-porosity and a biomimetic chemistry (Ca and P based), biopolymers permit to achieve good mechanical properties (in the range of healthy human cortical bone), while bioactive agents promote cell adhesion, proliferation and high hydrophilicity (essential also for blood absorption and thus sparkling chemical signals cascade for regeneration). Smartbone® is produced according to GMP (Good Manufacturing Practice) standards, applying only human-use approved components and CE mark is under obtainment for both conventional and unconventional shapes.

Thanks to the very high performances of Smartbone®, particularly its impressively higher mechanical properties with respect to other bone substitutes, IBI developed and launched custom-made products, “SmartBone® on demand™”, solving single specific cases of bone reconstruction: starting from a common CT scan, IBI can provide the adequate substitute for every kind of defect.

This technology was successfully applied to a custom reconstruction of the left cheekbone portion of a young man who was hit by a grenade during former-Yugoslavian war. Patient CT scan was acquired, a 3D real model was built by stereolithography, grafts were manually shaped on the real model while planning surgery. Mathematical files of the so obtained grafts shapes were used to pilto a CAM 5-axis machine to cut the final shape of raw materials that were then reinforced with IBI’s proprietary process. Once in operatory room, present residuals, applied aside the battlefield, were removed, leaving space for the custom made graft. Surgery was fast and very precise allowing to obtain a very satisfactory result both in terms of anatomical reconstruction and also functional.

SMARTBONE: a new composite bone substitute for reconstructive surgery SMARTBONE: a new composite bone substitute for reconstructive surgery
Date:2012
Journal:Second 30 Bologna lnternational Symposium and Workshop
Authors:

G. Pertici, G. Carusi, G. Perale

Abstract

Nowadays the loss of bone due to congenital defects, diseases, injuries and trauma, is the most common cause of reconstructive orthopedic surgery; it accounts, just in the maxillo-facial district, hundreds of thousand cases each year worldwide. Furthermore, bone cancers and sarcomas (for example Ewing’s disease), even if very often prematurely diagnosed and treated, request relevant bone tissue excise and this kind of operations are criticai not only for aesthetical issues but especially for the residuai anatomica) functionality for the patients
Very often there is a need to fill/rebuild the defect or the eliminated district and, for self-evident reasons, the use of autologous bone is strongly not recommended; moreover if the site involved is quite large, it is very difficult to get the right amount of bone from the patient. Nevertheless, autologous bone graft still plays the role of gold standard in criticai sized and non-union bone defects, the main reason being the Jack of adequate industriai substitutes (synthetic and xenograft materials). Hence, today’s most commonly used solution today stil! remains the cadaveric bone graft, which is sometimes the only one available. Beside all known criticai issues of these grafts (e.g. ethical, availability and costs), the deep washing, deantigenation and sterilization processes make allograft materials very fragile bone substitutes, unable to withstand typical heavy surgical manoeuvres.
Industrie Biomediche Insubri SA (IBI) developed a new technology to improve the properties of natural materials. Indeed, IBI produces Smartbone®, a bone substitute specifically developed for orthopaedic reconstructive surgery. This innovative scaffold has a composite structure based on a bovine derived bone matrix reinforced with biodegradable polymers and bioactive agents. The bovine derived matrix allows maintaining an adequate 3D-structure, with an open-porosity and a biomimetic chemistry (Ca and P based), biopolymers pennit to achieve good mechanical properties (in the range of healthy human cortical bone), while bioactive agents promote cell adhesion, proliferation and high hydrophilicity ( essenti al also for blood absorption and thus sparkling chemical signals cascade for regeneration). Smartbonéì is produced according to GMP (Good Manufacturing Practice) standards, applying only human-use approved components and CE mark is under obtainment for both conventional and unconventional shapes.
Thanks to the very high performances of Smartbone”, particularly its irnpressively higher mechanical prope1ties with respect to other bone substitutes, !BI developed and launched custom­rnade products, ‘·SmartBone”‘ on demandTM”, solving single specific cases of bone reconstruction: stmting from a comrnon CT scan, !BI can provi de the adequate substitute for every kind of defect.

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