Key points from article :
Clinical trial data demonstrates the potential to return function to paralysed upper limbs.
Each patient in the trial received one or more nerve repairs.
Augmented with one or both upper limbs, with 25 of 33 nerve repairs.
Resulting in functional recovery of muscles controlled by the repaired nerve.
Included injuries to the spinal cord, brachial plexus and other peripheral arm and hand nerves.
Follow-up data after one year was available for 16 of 19 patients involving 33 nerve repairs.
Of 33 nerve repairs, 25 resulted in functional recovery of muscles controlled by the repaired nerve.
Over half the nerve repairs using CelGro were performed in five quadriplegic patients.
Quadriplegic nerve transfers resulted in the best clinical outcome.
Paul Anderson, Orthocell Managing Director says
"... predictability, and consistency of return of muscle function following CelGro nerve regeneration treatment".
The company is preparing for discussions with the FDA on an approval pathway for CelGro.