Australian regenerative medicine company Orthocell (ASX:OCC) has announced the completion of recruitment in the Ortho-ATI shoulder tendon study it is conducting in collaboration with DePuy Synthes Products, part of the Johnson & Johnson Medical.
According to Orthocell managing director, Paul Anderson, “We are delighted to complete the patient recruitment phase of this highly focused randomised controlled trial (“RCT”), designed to assess the effectiveness of Autologous Tenocyte Injection (Ortho-ATI®) as a treatment to a difficult clinical problem with limited alternatives.”
The trial is led by Clinical Professor Allan Wang, Dr Jeff Hughes, Dr Jane Fitzpatrick and Professor Ming Hao Zheng at the University of Western Australia (UWA).
The company said patients were excluded from enrolling in the trial if they presented with any of the sixteen (16) exclusion criteria, including previous treatment injections in the prior three months, previous shoulder surgery or significant pathology of affected shoulder (eg inflammatory joint disease), or bilateral shoulder pathology.
It said the detailed exclusion criteria caused delays to the anticipated recruitment timeframes but that the approach is consistent with best practice and is not reflective of the significant patient population that is normally suitable for treatment with OrthoATI.
Orthocell said that in studies conducted to date, Ortho-ATI has been shown to be a cost-effective long-term, nonsurgical solution for difficult to treat tendons including the rotator cuff, elbow, gluteal, patellar and Achilles.
It said 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 per cent of adults over 50 years of age. These 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," said the company.