Orthocell unveils first clinical trial results for nerve regeneration platform CelGro

Regenerative medicine company Orthocell (ASX: OCC) has provided the first batch of evidence supporting the efficacy of its CelGro nerve regeneration platform.

The company published results of the first four patients to complete the clinical trial using CelGro, with patients experiencing an 83% improvement in muscle power.

The trial is ongoing and undertaken in association with leading West Australian orthopaedic nerve specialist, Dr Alex O’Beirne of St John of God Subiaco Hospital and Professor Ming Hao Zheng of the University of Western Australia.

Orthocell said it conducted the trial to demonstrate the effectiveness of CelGro and confirm that the platform can be used to guide and promote “tensionless nerve regeneration in damaged peripheral nerves of the hand and upper limb”.

If successfully proven, Orthocell plans to market its CelGro platform in Europe and other major markets globally. In the US, alone, over 20 million people suffer from peripheral nerve injury as a result of acute muscle injuries every year, at an annual cost of approximately US$150 billion (A$213 billion).

Geographical industry expansion

CelGro is a collagen medical device platform that improves soft tissue regeneration and can also be used for repair applications.

The treatment was first manufactured by Orthocell in WA and has now gone on to receive market authorisation in Europe – also known as the CE Mark – specifically for dental bone and soft tissue applications.

CE certification means CelGro can be marketed in the EU and is considered the first step to Orthocell obtaining further certifications around the world, now further boosted by the successful regenerative trial.

Orthocell said that seeing the first patients completing the trial “validates CelGro’s quality manufacturing and product performance and provides a strong foundation for indication expansion and regulatory approvals.”

One of the first territories being targeted by Orthocell is Australia. Earlier this month, the company submitted an application the Therapeutic Goods Administration (TGA) for CelGro approval.

Orthocell managing director Paul Anderson called the move an important milestone for the company and forecast entry to additional strategic markets in the foreseeable future.

“CelGro has shown to be the superior product when compared to current alternatives and I am excited by the commercial opportunities that lie ahead as we establish CelGro as the best in class collagen membrane,” he said.

Trial details

The study involves 20 patients with traumatic nerve injury requiring surgical repair. So far, Orthocell has treated 15 out of the allocated 20 patients with recruitment expected to be completed by the end of June 2019.

The first four patients treated in this “pivotal trial” had previously suffered traumatic peripheral nerve injuries following motor vehicle, sporting and work-related incidents, resulting in complete paralysis, or impaired use of the upper limb.

According to doctors who carried out the trial, the results were particularly striking because they were obtained from patients that were specifically selected because they experienced significant pain and were unable to perform basic activities of daily living such as eating, bathing, dressing or playing sport.

The clinical trial indicated that patients regained use of affected limbs “faster than expected” and that CelGro increased the strength and quality of repair conducted by surgeons, therefore making surgery more straightforward compared to before, according to Dr O’Beirne.

Prior to surgery with CelGro, the first four patients scored a muscle power of zero, with complete paralysis or significant difficulties in performing activities of daily living. Following CelGro nerve regeneration treatment, the four patients all scored a muscle power of four, which represents an 83% improvement in accordance with the British Medical Research Council Grading System.

“The nerve injuries suffered by the patients in this study were so severe that they would not have been able to regain normal use of their injured arm and hand without microsurgery,” Dr O’Beirne said.

“The surgery can be very complex and difficult, but using CelGro has enabled us to re-join severed nerves without tension. I am very pleased with the patients’ progress, regaining use of affected limbs faster than I would have expected and they continue to improve,”  Dr O’Beirne explained.

One of the four patients in the trial, Daniel Hunt, said that he is now “living a normal life” after suffering a football injury and losing all feeling in his right shoulder.

“The first patient outcomes are very positive with early results indicating CelGro is effective in guiding and regenerating peripheral nerves,” Mr Anderson said.

“This is an important step forward in the development of the CelGro platform in the area of human nerve regeneration. CelGro allows for tensionless reconnection of the damaged nerve while guiding nerve regeneration and accelerating the healing process,”  Mr Anderson added.

News of Orthocell’s successful clinical trial helped its shares to post a surging 113% gain with shares trading at $0.245 per share by midday.