Australian regenerative medicine company Osteopore (ASX:OSX) has secured clearance from the Research Governance Office (RGO) at Princess Alexandra Hospital in Brisbane for its clinical trial for jawbone regeneration.
The company is developing 3D-printed biomimetic and bioresorbable implants. It stated that the first patient is expected to be recruited within four weeks.
The single-arm feasibility study for maxillomandibular reconstruction seeks to recruit at least 10 adult patients in Australia by 2028. Each patient will be assessed 36 months post-surgery.
The study is investigating the safety and tolerability of Osteopore’s polycaprolactone-tricalcium phosphate (PCL-TCP) scaffold, used in conjunction with a vascularised corticoperiosteal tissue transfer technique, designed to regenerate bone in the maxilla and mandible. The maxilla and mandible bones support fundamental abilities such as breathing, chewing, swallowing, and speaking, while also contributing to facial appearance and psychological well-being.
Current treatments comprise autologous free tissue transfer, but this can lead to complications such as donor site morbidity, limited suitability for complex defects, a shortage of donor site bone, and insufficient bone height for effective dental rehabilitation.
Osteopore CEO Dr Yujing Lim said, “We are grateful that the necessary approvals have been obtained and that the first patient will soon be recruited to the study.
“The loss of substantial jawbone is a particularly debilitating condition, and through this study, we hope that the safety and tolerability of our proposed solution may be demonstrated."
“We look forward to continued momentum in the study, which will be another step closer to making this regenerative approach to jaw healing a reality for patients globally,” said Dr Lim.