Regenerative medicine company Orthocell (ASX:OCC) has announced that the Autologous Tenocyte Injection (Ortho-ATI) rotator cuff tendon study (RC Study) database has been locked.
This indicates the data has been signed verified by the clinical investigators and cannot be altered.
The company said the data has been submitted for analysis and it is on track to report top-line results in the fourth quarter of this year.
The RC Study was designed to assess the effectiveness of Ortho-ATI compared to corticosteroids as a non-surgical treatment to a difficult clinical problem with limited treatment options.
The company said that should the Ortho-ATI shoulder tendon study meet its objectives, it will be the first randomised cellular therapy study successfully completed for this indication anywhere in the world.
Orthocell managing director Paul Anderson said, “This is an important development milestone for OrthoATI and the Company and I am delighted to have reached this pivotal stage of the study.”
Currently, there are no proven long-term non-surgical solutions to repair chronic shoulder tendon injuries. Initial, conservative treatment options consist of rest, physical therapy, anti-inflammatory drugs and injectables.
These interventions may provide short-term pain relief. However, they do not repair the underlying pathology of chronic tendon degeneration and the risk of reinjury, or the likelihood of progressing to a full-thickness tendon tear.
The only remaining option if conservative treatments fail - is expensive surgery.