Maxillofacial Bone Regeneration

Bonus BioGroup commenced a clinical trial to evaluate the safety and efficacy of BonoFillTM in the treatment of human maxillofacial bone deficiency. BonoFillTM is regulated under the category of Advanced Therapy Medicinal Product (ATMP) that complies with the definition of Somatic Cell Therapies, and was developed according to GMP and GCP principles.

The study is a phase I/IIopen label, first-in-human clinical study, that will evaluate the ability of BonoFillTM to induce bone regeneration and to serve as a bone graft.

After the recruitment of each participant in the clinical trial for reconstruction of orthopedic bone loss and after the completion of all the preliminary tests required for his active participation, a fat tissue sample may be harvested from him. Within approximately two weeks of the fat tissue sample harvesting from a participant in the clinical trial, he will undergo a second-generation transplantation of an injectable live human bone graft.

From the fat tissue sample that was harvested from the patient’s body, the Bonus BioGroup's manufacturing lab, in Haifa, Israel, produces a variety of different cells that it needs for the production of a live human bone graft, it cultivates these cells under sterile and controlled conditions, in 3D structure, on biodegradable scaffolds, through a unique cultivation bioreactor system, that simulates the conditions necessary for bone tissue production in the human body, and from them it makes the second generation of injectable live human bone graft, within approximately only two weeks after harvesting a fat tissue sample from the patient.

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