Regenerative medicine company Orthocell (ASX:OCC) has announced the publication of positive pre-clinical and clinical results for the use of its CelGro in enhancing repair of critical bone defects in the 'Tissue Engineering' Journal.
The paper is entitled 'Collagen Membrane for Guided Bone Regeneration in Dental and Orthopedic Applications'.
The company said the publication, in conjunction with previous pre-clinical studies published in Biomaterials, demonstrate CelGro dosed with bone growth factors significantly improved the healing of cortical bone.
It said it also validates that it is an ideal membrane for Guided Bone Regeneration (“GBR”) not only in oral maxillofacial reconstructive surgery but also in orthopedic applications such as open tibial fractures and incidences of non-union fractures.
Orthocell managing director, Paul Anderson, said, “We are delighted with the publication of the positive pre-clinical and clinical results indicating CelGro aids in accelerating the repair of difficult to treat critical bone defects.
"These are exciting results as they further demonstrate the potential to extend the applications of CelGro representing an area of significant clinical interest to the maxillofacial and orthopaedic community.”
In May 2018, Orthocell announced the results of a clinical study designed to evaluate the performance of CelGro in dental GBR treatment.
Dental GBR is a standard procedure used routinely in clinical practice, to preserve and restore bone volume to facilitate the subsequent placement of dental implants.
The clinical study involved a two-stage dental implant procedure with GBR in 10 patients (involving 16 dental implants). Bone defects were covered with the CelGro collagen membrane after bone void filling.
The company said various assessments related to the performance of the CelGro collagen membrane were evaluated up to six months post GBR treatment.
"Top line data indicated that use of CelGro resulted in successful bone regeneration within 4 to 6 months of the procedure, enabling the next stage of implant surgery (placement of the crown). Further, the void-filling material was fully integrated into the newly regenerated bone, with no reported complications or adverse events," said the company.
Lead author and chief investigator, Dr Brent Allan, said, “My experience in using CelGro in dental implant procedures has given me the confidence to use it in more complex Orthognathic procedures. These surgeries are life-changing and technically demanding. Predictable and high-quality bone regeneration is of upmost importance to deliver functional, as well as aesthetically pleasing outcomes for patients.”