PERTH, Australia--(BUSINESS WIRE)--Regenerative medicine company Orthocell has been granted ethics approval for a human study examining the effectiveness of its CelGro® collagen medical device, to guide and promote nerve regeneration in severed peripheral nerves of the hand and upper limb.
The primary objective of this study is to demonstrate the safety, tolerability and effectiveness of CelGro® when used as a conduit in the surgical repair of peripheral nerve injuries. The study will involve 20 patients who have suffered injury to one or more peripheral nerves and will be undertaken at St John of God Hospital beginning in the fourth quarter of calendar 2016.
Peripheral nerve injury is most commonly caused by accidents or other trauma and in the US alone, over 20 million people are affected each year, at a cost of approximately $150 billion in annual health care dollars.
Principal investigator, orthopaedic surgeon Dr Alex O’Beirne said: “This is an exciting development that has the potential to improve patient outcomes by allowing for a suture-less repair to the damaged nerve, to guide nerve regeneration and accelerate the healing process.”
CelGro® is a biological medical device used as a scaffold for a variety of orthopaedic and general reconstructive surgical applications. Orthocell is also undertaking clinical studies using CelGro® to augment repair of the rotator cuff tendon within the shoulder, as an augment to guide and promote bone regeneration, as well as an augment to cartilage repair within the hip joint.
Orthocell Managing Director Paul Anderson said, “This is an exciting new phase in the development of CelGro® and its use as an augment to improve nerve repair. It further validates CelGro as a unique platform technology for soft tissue repair.”
Orthocell has submitted CelGro® for first regulatory approval in Europe and expects to receive notice of approval of its CE Mark application in 2016. Receipt of this approval will enable sales of CelGro® to commence in Europe, and trigger applications for other regulatory approvals in the United States, Australia and Japan in 2017.
About Orthocell Limited
Orthocell is a commercial-stage, regenerative medicine company focused on regenerating mobility for patients and our ageing population by developing products for a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-approved stem cell therapies Autologous Tenocyte Implantation (Ortho-ATI™) and Autologous Chondrocyte Implantation (Ortho-ACI™), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is CelGro™, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approvals.