Details

Project title: Bioactive Bone Substitutes
Acronym: B.B.S.
Coordinator: Intrauma Srl

Type: Project (Interpolo with New Materials Pole – bioPmed lead partner)
Annuality: Third
TP/LS membership: TecnInn/HMNA2
Subjects involved: Traumavet, Laboratori Biomicron, University of Turin, Polytechnic of Turin

Status: Completed
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Abstract: The aim of the B.B.S. project was to make an innovative bone substitute with the following properties:

  • biocompatibility
  • bioactivity
  • osteoconduction
  • osteoinduction
  • morphology
  • bioresorbability

In detail, the project involved the fabrication of biomimetic bone substitutes, characterized by a structure and composition similar to that of healthy bone tissue, suitably functionalized for bone regeneration in the orthopedic, trauma, spinal, and maxillofacial fields by controlled release of growth factors.

Name: Piero Costa
Organization: Intrauma S.r.l.
Address: Via Rovigo 4, 10098 Rivoli (To)
Phone: 011.9539496
Fax: 011.9588385
E-mail: piero.costa@intrauma.com
WEB: www.intrauma.com

THE PROBLEM ADDRESSED

The aim of the B.B.S. project is to provide a bone substitute with osteoconductive and osteoinductive properties through the fabrication of an appropriate ceramic scaffold (osteoconductive) having the morphological, chemical-physical and mechanical characteristics compatible with the graft site and promoting
osteoinduction with controlled amounts of growth factors released from the bone substitute itself.

In this context, the BBS project proposes:

  • An innovative design, consisting of a porous ceramic scaffold (osteoconductive) appropriately
    functionalized by layer-by-layer technique to obtain nano-coatings in material
    natural polymeric;
  • The simultaneous presence of a ceramic material scaffold and polymeric nano-coatings
    to enable a ‘biomimetic’ bone substitute to be obtained, having the same structure and
    composition of natural bone;
  • The composition, based on chitosan and chondroitin sulfate, of the nano-coatings, which allows the
    significantly reduce the cost of the final device, compared with other bone substitutes currently in
    collagen-based trade, which require high process and production expenses.
  • Controlled release of osteomorphogenic proteins after optimized
    incorporation of growth factors into the multilayer by direct uptake of BMP2 in the
    positively charged layers (as BMP2s are positively charged) ;
  • Definition and development of instrumentation and surgical techniques of bone substitutes that ensure
    simplicity of implantation, with modalities aimed at minimizing incisions on the patient,
    ensuring very rapid functional recovery.

THE ACTIVITIES CARRIED OUT

The B.S.S. Project involved two small and medium-sized enterprises, the University of Turin and the Polytechnic of Turin. The scope of the project is bone substitutes for use in trauma and orthopedics, human and veterinary. The main objective of the project, which was particularly innovative and singular, was to create a bone substitute that would essentially have Biocompatibility, Bio-activity, and Osteoinduction characteristics at least comparable with products on the market, providing osteoinduction optimized by pore morphology and controlled release of growth factors defined as BMPs (Bone Morphogenetic Proteins), such that the implanted synthetic material would be absolutely biomimetic and have mechanical characteristics comparable to natural bone tissue. In addition, the features of a bioreactor were implemented by adapting it to handle specific tests on bone substitutes. The secondary goals of the project were to develop an instrumentarium and surgical technique such that a minimally invasive approach could be taken when implanting functionalized bone substitutes on the patient. The project partnership actively cooperated within the project to achieve all the budgeted goals. Bone substitutes were optimized to make them compliant in their physicochemical, mechanical, size and release kinetics in both human and veterinary settings.

PROJECT RESULTS

The project partnership achieved all the goals budgeted at the beginning of the activities, increasing during the course of the project the mutual cooperation and expertise of all partners.

In particular, the following technological goals were achieved:

  • Definition of a stable and repetitive method for the production of ceramic scaffolds made of -TCP enriched with Bioglass CEL2 to optimize the stability of chemical-physical characteristics and mechanical properties;
  • Definition of a stable and repetitive method for biomimetic functionalization with natural polymers (chosen by the partnership chitosan and chondroitin sulfate) that allow functionalization with BMP2 growth factors;
  • Definition of an effective method for the synthesis of BMP-2 growth factors;
  • Definition of a macro-protocol for the production of controlled-release functionalized growth factor bone substitute;
  • Implementation of features of a Bioreactor for the characterization of bone and related substitutes, however functionalized and engineered;
  • Fabrication of a dedicated instrumentarium for implantation of functionalized release bone substitutes
    controlled, allowing a minimally invasive approach for use in human and veterinary garments (filling bone gaps or for adjunctive osteotomy surgeries in joint ends).

PROJECT NUMBERS

  • Other Private Partners: Laboratori Biomicron S.r.l.
  • Other Public Partners: Polytechnic of Turin, University of Turin
  • Total number of partners: 4
  • Number of employed researchers (fixed-term and permanent and co.co.pro.) involved: 19
  • Duration in months: 30
  • Total budget: 702.471,24 €
  • Funding: 419.175,49 €
  • Number of presentations at conferences and seminars: 1
  • Number of permanent, fixed-term and co.co.pro. jobs created: 5
  • Number of jobs retained at the end of the project: 1
  • Number of public researchers involved: 7