Osteopore (ASX: OSX) will further refine its next generation scaffolds after agreeing to sponsor two clinical trials for its regenerative implants in Australia.
Under a new agreement, world recognised Queensland-based plastic and reconstructive surgeon Dr Michael Wagels will lead two human clinical trials that will run up to five years.
The trial will use Osteopore’s next generation 3D printed medical grade polycaprolactone/tricalcium phosphate (PCL-TCP) scaffolds.
Osteopore will supply the scaffolds where they will be implanted in patients.
The two trials are single-arm feasibility studies and will recruit 10 patients each.
After they’ve received the implant, Dr Wagels and the team at the Australian Centre for Complex Integrated Surgical Solutions will follow the patients closely for up to five years.
Patients in the study will be treated at Brisbane’s Princess Alexandra Hospital and will be supported by the Herston Biofabrication Institute.
One study will evaluate the PCL-TCP scaffold in reconstruction of upper cranial defects, while the other will assess the same system in the reconstruction of lower limb bone defects.
Osteopore chief technology officer Dr Lim Jing said the trials were an “important milestone” in advancing the second-generation implants.
“The study aims to clinically validate our regenerative solution for cranioplasty and cements our standing in the field of in-situ engineering.”
Building on previous results
The new trials have been instigated following in encouraging results in several first-in-human cases.
These cases included reconstruction of two tibias, one midface, two mandibles and one skull.
Dr Wagels previously conducted three world-first operations using Osteopore’s implants.
“We know from the operations we have performed that the technology can have a life-changing effect of patients’ lives,” he said.
“These implants and the technique we have pioneered to implant them are the beginnings of a new and exciting era in regenerative medicine.”
“We now have an opportunity to treat more patients in the same way and to study their outcomes in great detail, which will build on existing knowledge,” Dr Wagels added.
Osteopore expects the trials will validate the clinical technique of using the corticoperiosteal flap in combination with these next-generation products.
The company hopes to use the extra data to support further market penetration.