Landmark clinical trial set for human maxillofacial bone deficiency

TRANSPLANT manufacturer Bonus BioGroup reports that it has obtained the required number of patients for its landmark clinical trial to treat human maxillofacial bone deficiencies by viable autologous human bone transplants.

 

Twenty patients have been recruited for the program, which is the maximum number of participants approved for the said clinical trial.

 

In April 2014, the Bonus BioGroup launched the clinical trial for the repair of maxillofacial bone deficiency, including upper and lower jawbone cavitation, by transplantation of live human bone grafts. These grafts, also termed transplants, are autologous or comprised of cells originating from patients' own fat tissue. The endpoint of the clinical trial is to evaluate the transplants’ safety and efficacy.

 

Bonus BioGroup produces personalized, autologous viable human bone transplants utilizing unique technology that combines various scientific disciplines and processes such as biology, tissue engineering, material engineering and tailored medicine.

 

The transplants are manufactured in Bonus BioGroup’s production facility at Matam Advanced Technology Park, Haifa, Israel. The facilities and clinical trial activities, starting from the development stage to production, quality control and product supply, are Good Manufacturing Process (GMP) as well as ISO-9001 certified.