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Sunday, 06 April 2014 07:40

Bonus BioGroup Has Commenced a Clinical Trial to Transplant Live Bone Grafts in Human Facial Bones

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A Human Bone Grown in a Lab to Be Transplanted in Humans:

Bonus BioGroup Has Commenced a Clinical Trial to Transplant Live Bone Grafts in Human Facial Bones

logo4footerBonus BioGroup announces it has commenced a clinical trial for the repairing of human facial bone deficiency, including upper or lower jaw bone deficiency, using a live human bone graft, produced in the company's production facility, in Matam Industrial Park, Haifa. 

Bonus BioGroup produces live human bone grafts, based on cells extracted from the patient's own fat tissue, using the company's state-of-the-art technology, which combines biology, materials engineering, tissue engineering and personal medicine.

The first stages of the clinical trial have been successfully accomplished for the first patient recruited: obtaining fat tissue sample, transporting the sample safely to Bonus BioGroup's production facility and there, extracting the cells required for the generation of a live human bone graft.

The manufacturing process of the human bone graft began outside the production facility, when a fat tissue sample was obtained from the first patient enrolled in the live human bone graft transplant clinical trial. The sample was then transported, within a few hours, to the company's production facility, where the required cells for bone generation were extracted and the bone growing procedure has begun.

The production of the live bone graft is expected to be completed in approximately a month, and result in a bone graft ready for transplant in the patient whose sample was used to grow it. Approaching the scheduled date of the transplantation procedure, the graft will be transferred to the transplant site.

The first live human bone graft produced by Bonus BioGroup is expected to be fully accepted by the patient's body; as the patient's own tissue was used to produce it, the immune system, when facing the autologous graft, is expected to identify it is biologically similar, thereby preventing the immune system's reaction towards rejection, common in allografts (transplantations using tissue from a foreign donor).

In the upcoming weeks, Bonus will complete the fat tissue sample collection from all 20 patients expected to participate in the clinical trial to fill varying bone deficits in the facial bones.

First interim results are expected 4 months after the first bone graft transplantation in each patient.

The facial bone deficit repair clinical trial's goal is to test the safety and efficacy of Bonus BioGroup's live human bone grafts, and it is intended to conclude within one year of the last graft transplantation.

Bonus BioGroup's production facility was designed, established and qualified in compliance with the European Good Manufacturing Practice standards (GMP), required for producing cellular medicine products of the quality matching clinical application in humans. The facility allows Bonus BioGroup full control over the entire bone graft growing process, independently of any substantial collaboration or other parties.

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