CE17 - Recherche translationnelle en santé

Osteoinductive implants for the regeneration of critical-size bone defects – OBOE

Submission summary

To date, the repair of critical sized bone defects remains a clinical unmet need. Autograft, the current gold standard, presents several drawbacks justifying safer strategies. “Orthobiologics” products that combine synthetic grafts, mostly collagen sponges and ceramics, and bioactive molecules such as growth factors, are appealing since they actively trigger stem cell differentiation in situ to form new bone. Inductos ® is the most widely used, delivering BMP-2 combined with collagen. It presented adverse effects due the too high dose of BMP-2 delivered and extensive off-label use. Being able to reduce the dose of BMP-2 and to confine it locally in an appropriate material carrier, in order to deliver it with improved safety and efficacy, would considerably broaden the perspectives of its clinical use.
We have engineered a biomimetic coating that delivers BMP-2 locally from the surface of any type of implants, whatever their chemistry (ceramics, metals and polymers) and shape. We have already proved that film-coated implants are osteinductive in small animal models and that it is possible to repair a 3D volumic bone defect via the osteoinductive coating of a hollow cylinder made a PLGA, a widely clinically used synthetic polymer. The regenerated bone, composed of cortical and trabecular bone, was also vascularized.
The translation of this innovative nanocoating toward the clinics requires to further prove the efficacy of the osteoinductive film to repair a critical size defect in large animals and its safety.
OBOE aims to advance the pre-clinical translation of this innovative orthobiologics. Our goal is to repair a large bone defect in large animals by controlling independently the 3D architecture of the implant and the dose of BMP-2 delivered via the osteoinductive coating. We have selected synthetic polymers as 3D architecture scaffolds in view of their versatility and adaptability to advanced printing techniques.
OBOE is organized in 3 workpackages. In WP1, we will design and test the architecture of a 3D polymeric implant and will optimize the biomimetic film coating. In WP2, we will evaluate the safety (biocompatibility and biodegradability) of the osteoinductive coating following the regulatory requirements. In WP3, we will evaluate the efficacy of the film-coated implant for the repair of a critical-size defect in a large animal model (sheep).
OBOE gathers 4 partner labs (LMGP and IAB in Grenoble, CIC-IT in Bordeaux and B20A in Paris) in a multidisciplinary network that leverages expertise in biomaterials, in vivo imaging and small animal models, regulatory affairs, bone tissue engineering and in vivo pre-clinical trials in large animals. We will take benefit from the key technical expertise of the team members and using several technical platforms for biotechnologies and the imaging of small animals in Grenoble, for technical medical innovation in Bordeaux and for experiments in large animals in Maisons-Alfort.

Project coordination

Catherine PICART (BRM - Biomimetism and Regenerative Medicine)

The author of this summary is the project coordinator, who is responsible for the content of this summary. The ANR declines any responsibility as for its contents.

Partner

CIC-IT CIC BORDEAUX
IAB INSTITUT ALBERT BONNIOT - Ontogenèse et Oncogenèse Moléculaire
BRM BRM - Biomimetism and Regenerative Medicine
B2OA Laboratoire de Bioingénierie et Biomécanique Ostéo-articulaires

Help of the ANR 716,114 euros
Beginning and duration of the scientific project: - 36 Months

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