Princess Alexandra Hospital has launched a clinical trial to rebuild jawbones with Australian-Singaporean regenerative medicine company Osteopore.
The trial for maxillomandibular reconstruction (jawbone) is recruiting 10 adult patients from Australia with recruitment anticipated by 2028 and patient follow-up expected to be 36 months post-surgery.
The loss of bone in the maxilla or mandible can significantly impact function and appearance, affecting basic abilities such as breathing, chewing, swallowing and speaking. These bones also play a key role in facial aesthetics, which is closely linked to psychosocial well-being.
The trial seeks to determine the safety and tolerability of 3D-printed biomimetic and bioresorbable implants already used with success in other bone reconstructions at PA Hospital (PAH) under the leadership of plastic and reconstructive surgeon, Dr Michael Wagels.
In launching the trial, Dr Wagels said there was a robust body of evidence, including PAH’s in-human series, which suggested the regenerative matching axial vascularisation (RMAV) technique facilitates bone regeneration and is preliminarily safe and well-tolerated.
“The overarching goal of this project is to lay the foundation for future research, which refines the approach to maxillomandibular reconstruction in a way that minimises patient morbidity and mortality by using modern advances in tissue engineering.
“We aim to further the use of RMAV and hope that the study lays the foundation for future randomised clinical trials in which RMAV is compared to the current gold standard,” said Dr Wagels.
RMAV had been successfully applied with the Company’s polycaprolactone-tricalcium phosphate (PCL-TCP) scaffolds in previously conducted cranial and long-bone reconstruction trials.
Osteopore Limited is a global leader in 3D-printed biomimetic and bioresorbable implants and CEO Dr Yujing Lim, said the company was delighted to grow clinical collaborations with PA Hospital and Dr Wagels.
“Focusing on regenerative medicine, we are committed to identifying key clinical applications for our technology, while continuously advancing product development.
“This collaboration leverages our strengths in technology and product development, alongside precise clinical needs identification.
“Our previous collaboration with the Hospital contributed to our recent European market approvals, and we look forward to creating more collaborations of this nature,” said Dr Lim.
The Human Research and Ethics Committee (HREC) at Metro South Health has provided clearance, while Research Governance Office (RGO) clearance is expected to follow suit.
Full ASX Release from Osteopore Ltd is here.