Orthocell (ASX: OCC) published yet another batch of trial results relating to CelGro which it says validates its claim that the technique can deliver higher quality nerve repair compared to existing methods.
Earlier this morning, the regenerative medicine company published positive pre-clinical results for the use of CelGro in enhancing repair of severed peripheral nerves.
The new results provide evidence of CelGro restoring nerves to their normal or pre-injured structure, which is not possible to be examined as part of the current human nerve regeneration trial.
More specifically, the results of the pre-clinical study showed that use of CelGro for peripheral nerve repair in rats “induced a complete regeneration of nerve fibres which were indistinguishable from normal nerve histology,” the company said.
CelGro showed superior outcomes in restoring nerve structure and functional recovery when compared to the traditional direct suturing nerve repair technique.
“The results reinforce the initial patient outcomes previously reported from our current human clinical study demonstrating the return of sensation and muscle function in affected limbs following CelGro nerve regeneration treatment. Restoring normal nerve structure is critical for regaining mobility, function and quality of life,” said Paul Anderson, managing director of Orthocell.
Repair of damaged peripheral nerves often involves reconstructive surgery and the use of sutures to reconnect nerve endings.
This method has been the go-to method for clinicians for decades but has been shown to result in suboptimal sensory and functional patient outcomes. In other words, undesirable side-effects as a by-product of suturing.
Some of the typical problems encountered by clinicians are that sutures are unable to seal the nerve and are thus incapable of preventing leakage of important intraneural fluids from the regenerating nerve.
Furthermore, nerve suturing is technically demanding to apply for direct repairs and often induces detrimental scarring that impedes healing and functional recovery.
At a microscopic level, Orthocell’s pre-clinical study on animals demonstrated that the company’s collagen medical device produces superior nerve repair in severed peripheral nerves when compared to the traditional repair method using sutures.
The pre-clinical study was conducted with 30 rats across three study groups including a control group, a direct suture method and group using the CelGro repair method.
Orthocell said that CelGro maintained alignment of nerve ends during reconnection while noting that “suturing caused scarring and fibrosis impeding nerve growth leading to disordered nerve alignment and inferior repair”.
Tensionless and sutureless repair of peripheral nerves is of significant clinical interest to the surgical community including orthopaedics and neurosurgery, given that the potential improvements in efficacy and efficiency of surgical procedures.
By developing a method of repairing nerves without sutures, Orthocell hopes to offer surgeons the chance to reduce surgery time and the risk of additional trauma to soft tissue.
From animals to humans
In relation to humans, CelGro is also making developmental progress. Orthocell recently announced that four patients successfully completed participation in the CelGro nerve regeneration clinical trial.
Following surgery with CelGro, patients experienced an 83% improvement in muscle power of affected limbs and had returned to work, sport and normal daily activities.
In previous studies, CelGro has already been shown to improve tissue growth, augment repair of the rotator cuff tendon within the shoulder, guide bone regeneration in the jaw and assist in the re-joining of severed peripheral nerves.
With both animals and human trials ongoing and Orthocell fully committed to advancing CelGro towards public availability as soon as possible, the company confirmed that it plans to gather further patient data and will provide a clinical update in the third quarter of this year.
Shares in Orthocell rose over 12% to trade at $0.505 in morning trade.