BonoFill^TM – A Novel Tissue-engineered Autologous Bone Graft generated from Adipose Tissue derived Mesenchymal Stem Cells for the Treatment of Maxillofacial Bone Tissue Regeneration

Objective: Bonus BioGroup has developed a novel tissue-engineered, three-dimensional, high-density, autologous bone graft designed to overcome the limitations associated with current maxillofacial bone reconstruction treatments. The BonoFill^TM graft is generated from the patient’s own adipose tissue-derived mesenchymal stem cells grown on mineral scaffold particles. Pre-clinical studies demonstrated BonoFill^TM’s superior osteoconductive and osteoinductive properties, as well as promotion of de novo bone formation and graft integration. We present here the safety and efficacy results of BonoFill^TM first-in-man phase I/II clinical study for maxillofacial bone tissue regeneration.

Methods: A phase I/II open label, first-in-man clinical study was conducted to evaluate the safety and efficacy of BonoFill^TM as a bone graft for the reconstruction of maxillofacial bone tissue in two clinical indications:

• Bone augmentation
• Bone grafting

Eleven eligible male and female subjects aged 49-65 years were enrolled, underwent liposuction and were treated with BonoFill^TM. Clinical follow-up was performed throughout a period of six months after BonoFill^TM treatment and included blood work, X-rays, CT scans and biopsies collected from the transplantation site.

The autologous BonoFill^TM bone graft was manufactured at a GMP-certified clean room facility, and the study was conducted in Israel under local IRB approval.

Results: The study results demonstrate that BonoFill^TM promoted fast, high-quality bone tissue regeneration without complications. There were no incidents of chronic bone infection (Osteomyelitis), no significant changes in complete blood count (CBC), and the patients reported overall good health during the duration of the study. At trial end, the BonoFill^TM treated sites were found in all patients suitable for dental implant placement.

Conclusion: BonoFill^TM treatment resulted in newly-generated bone of high density, which provided a high-quality stable support for placement of dental implants. Thus, BonoFill^TM is a promising novel solution for bone tissue repair in maxillofacial indications.