Orthopedic

In August, 2017 Bonus announced the first live human bone graft, grown outside the patient's body, transplanted into a patient’s arm as part of a clinical trial for reconstruction of extensive critical bone loss in bones of the extremities.

The clinical trial for reconstruction of orthopedic bone loss, is conducted for two indications: (1) extensive critical bone loss in a long extremity, that failed to heal, whether in the case of a non-union of the extremity through the body’s autonomous reconstructive capability without therapeutic intervention or in the case of failed healing, despite an attempt to reconstruct the extremity through an orthopedic therapeutic process; and also (2) a comminuted extra-articular fracture in a long extremity bone.

The clinical trial for reconstruction of orthopedic bone loss may include 30-40 participants, men and women, 18-75 years of age. In the first part of this trial, 10 participants will be recruited for both clinical indications of the trial, combined; in the second part, at least 10 additional participants will be recruited in each of these two clinical indications, and up to 30 additional participants for both clinical indications, combined.

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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