Orthocell Ltd (ASX:OCC) has had the positive pre-clinical and clinical results for the use of CelGro® in enhancing repair of critical bone defects published in the highly regarded Tissue Engineering journal.
In conjunction with previous pre-clinical studies published in Biomaterials demonstrating that CelGro dosed with bone growth factors significantly improved the healing of cortical bone, this validates that CelGro is an ideal membrane for Guided Bone Regeneration.
This is not only in oral maxillofacial reconstructive surgery but also in orthopedic applications such as open tibial fractures and incidences of non-union fractures.
“Demonstrate potential applications”
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.”
Clinical study on dental GBR treatment
In May 2018, Orthocell announced the results of a clinical study designed to evaluate the performance of CelGro in dental GBR treatment which 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) where bone defects were covered with the CelGro collagen membrane after bone void filling.
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.
“High-quality bone regeneration”
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.”
Pre-clinical study results
The pre-clinical study also reported in the publication was conducted in a large animal model designed to assess the effectiveness of CelGro to enhance the repair of cortical bone defects, when used in conjunction with autograft bone.
CelGro showed superior cortical bone alignment and reduced porosity at the defect interface, when compared to current market leading GBR product Bio-Gide.
Micro-CT evaluation showed early bridging over the defect area 30 days post-operatively, and nearly complete restoration of mature cortical bone at the bone defect site 60 days post-operatively.
Histological analysis at day 60 after surgery, further confirmed CelGro supported the regeneration of higher-quality bone, having a similar thickness and density to normal cortical bone.
In addition, use of CelGro in combination with autograft bone, resulted in significantly increased bone formation at the defect - compared to repair without the use of autograft bone.
Orthocell intends to leverage CelGro’s ability to guide superior quality bone formation to further position CelGro as the best-in-class collagen membrane for bone and soft tissue repair.
The performance studies underpins the compatibility and versatility of CelGro as a platform technology and highlights the potential to extend Orthocell’s innovative product range into orthopedic bone regeneration.
CelGro® is approved for use in the EU for GBR and soft tissue reconstruction and is currently under review for approval by the US FDA and the Australian Therapeutic Goods Administration (TGA).