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.