Clinical Trial to Assess Effectiveness of Autologous Tenocyte Injection (Ortho-ATI®) compared to corticosteroid Begins in Australia

Australian regenerative medicine company Orthocell Limited today announced that it has recruited and treated its first patient in a randomised, controlled clinical trial of Ortho-ATI® versus corticosteroid injection, for the treatment of rotator cuff tendinopathy and tear in the shoulder.

Rotator cuff tendinopathy and tear (which manifests as severe shoulder pain) is a common and often difficult injury to treat and affects more than 50% of adults over 50 years of age. Rotator cuff injuries may lead to considerable disability, reduced quality of life, and absenteeism from work, and are a significant burden on healthcare resources. This burden is expected to increase as the population ages, and as a result, new treatments are required that address the underlying pathology of the injury, not just the symptoms.

The objective of this clinical trial is to assess the effectiveness of Autologous Tenocyte Injection (Ortho-ATI®) compared to corticosteroid injection in the treatment of rotator cuff tendinopathy and tear. To be eligible for the trial, patients must have failed previous conservative treatment options, including previous injection treatment and physiotherapy. The trial will be led by Clinical Professor Allan Wang, President of the Australian Elbow and Shoulder Society, Clinical associate Professor Bill Breidahl and Professor Ming Hao Zheng at the University of Western Australia (UWA).

Orthocell Managing Director Paul Anderson said: “Demonstrating the efficacy of Ortho-ATI® for the treatment of rotator cuff tendinopathy is an important element of our product development and partnering strategy. We expect results to show Ortho-ATI® is a durable and effective treatment for degenerative shoulder injuries.”

In studies conducted by Orthocell to date, Ortho-ATI® has been shown to be a cost effective long-term and durable, non-surgical solution for difficult to treat tendon injuries. Ortho-ATI® is available in Australia, New Zealand, and Hong Kong with regulatory oversight for patients who have failed conservative treatment options such as corticosteroid injections and exercise programs and have ongoing symptoms.

Orthocell is a regenerative medicine company developing products for the repair of a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-licensed 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.

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