Ann: CelGro Nerve Regeneration Results in Quadriplegic Patients, page-89

Great article in the Australian Business Review an hour ago...

Orthocell shares boosted by nerve repair trial success


Orthocell says its CelGro drug has helped patients regain muscle function. Picture: IStock

• SARAH-JANE TASKER
  REPORTER
  
• AN HOUR AGO OCTOBER 9, 2019

Regenerative medicine company Orthocell has reported positive results from a trial of its nerve repair product, in which a quadriplegic patient regained arm and hand functions.
News of the interim clinical trial results boosted the Australian-listed company’s shares on Wednesday, with the stock up 21.5 per cent at 48c.
Orthocell said that following surgery with its product CelGro, patients had regained muscle function in their affected limbs and had either ceased or significantly reduced prescription pain medication.

CelGro is a collagen medical device, which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications.
Patients participating in the clinical trial had previously suffered traumatic nerve injuries following motor vehicle, sporting and/or work-related incidents, resulting in impaired use of the affected limbs and, in more severe cases, quadriplegia.
A clinical follow-up of the first 12 participants, 12 months after surgery, found voluntary muscle movement was restored in 96 per cent of nerve repairs and 86 per cent of patients who required prescription pain medication, including opioid-based medications, were able to significantly reduce or stop their medication completely.
Orthocell’s clinical trial, which aims to demonstrate the effectiveness of CelGro in improving patient outcomes after nerve repair, will investigate 20 patients who had an injury that severed the connection between the peripheral nerves in the arm, brachial plexus or spinal cord, causing loss of function or paralysis in the arm and/or hand. CelGro will be used together with microsurgery to repair the damaged nerves and re-establish the connections to target muscles.
The first 12 study participants included three quadriplegic patients. The interim review, 12 months after treatment, showed that in the quadriplegic patients, 73 per cent of nerve repairs resulted in meaningful functional recovery of affected muscles in the 12 months. A quadriplegic patient with complete paralysis regained sufficient arm and hand function to perform tasks such as brushing teeth, drinking from a cup, and transferring into and out of his wheelchair.
“Seeing one of our patients progress from no strength in his arm, and no movement in his fingers and thumb, to playing wheelchair rugby is extremely encouraging for our researchers and clinical partners,” Orthocell managing director Paul Anderson said.
“Off the back of these positive interim results, our team is accelerating regulatory applications in the US, EU and Australia to make this treatment accessible to the more than 700,000 people who experience nerve damage annually.”
Australian orthopaedic nerve specialist and clinical trial lead, Alex O’Beirne, said observing the positive progress of the initial patients gave him the confidence to use CelGro in more severe cases, such as quadriplegia.
“The microsurgery required to return arm or hand function to quadriplegic patients is complex and challenging, and can require multiple nerve repairs,” he said.
“CelGro facilitates tensionless repair, and can prevent regenerating nerves being compressed or trapped by scar tissue.”