- Bonus BioGroup commenced a clinical trial to evaluate the safety and efficacy of BonoFillTM in the treatment of human maxillofacial bone deficiency. BonoFillTM is regulated under the category of Advanced Therapy Medicinal Product (ATMP) that complies with the definition of Somatic Cell Therapies, and was developed according to GMP and GCP principles.
- The study is a phase I/II, open label, first-in-human clinical study, that will evaluate the ability of BonoFillTM to induce bone regeneration and to serve as a bone graft. Recruitment for this study is complete.
- The study includes the following stages:
- Harvesting of a fat tissue sample from the patient
- Transportation of the sample to Bonus BioGroup's manufacturing facility
- Extraction of cells from the sample tissue
- Cell cultivation and production of the human bone graft
- Transportation of the graft back to the medical center
- Transplantation of the graft into the patient's bone defect
As the manufactured human bone grafts originate from autologous fat samples, the company expects the grafts to be fully tolerated and to not induce any immune response or graft rejection.