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Thursday, 16 January 2014 07:43

Bonus BioGroup to Commence Clinical Trial Received Approval for Live Human Bone Graft Transplant

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Bonus BioGroup to Commence Clinical Trial Received Approval for Live Human Bone Graft Transplant

logo4footerBonus BioGroup announces today it has received approval for clinical trial, in cases of facial bone deficiency, including upper or lower jaw bone deficiency. The repair of the facial bone deficiency will be performed by using a live human bone graft, produced in Bonus BioGroup's production facility, in Matam Industrial Park, Haifa. 

The manufacturing process of human bone grafts starts outside the production facility, in a clinic, by obtaining the patient's blood sample and liposuction. The samples are then transported to the production center, where the stem cells required for growing the graft are produced from the fat tissue.About a month later, a live human bone graft is formed, customized for the patient whose samples were used and ready to be transplanted. The bone graft is then transferred from the production center to the medical center where the transplant is performed.

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.

Dr. Shai Meretzki, Bonus BioGroup's CEO, noted "engaging in clinical trials of the company's products transplantations in humans is an important milestone for the company, not only in realizing its independent production capacity but also in the news it presents to millions worldwide, who may achieve a complete cure thanks to Bonus BioGroup's innovative technology.

The clinical trial of completing facial bone deficiency is designated to test the safety and efficacy of the company's live human bone grafts. We estimate the initial patient recruitment for the clinical trial, which is expected to last a year after transplants, will begin in the upcoming few weeks".

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