Orthocell gains approvals for initial human trials |  Aug 31, 2007

Orthocell is one step closer to providing improved treatments for patients suffering from rotator cuff and other tendon injuries having recently gained Australian ethics and regulatory approvals for the initial human trial of their new ATT technology.  These trials will focus on the safety and tolerability of the technology, which uses the patients’ own tissue, for the repair and regeneration of damaged and diseased tendon tissue.  This technology has the potential to deliver the first truly effective regenerative solution for tendonopathy related injuries.
It is believed this will be the first clinical study of this type globally. Approvals have been received from the Sir Charles Gairdner Hospital Ethics Committee and the TGA to enrol up to 30 patients for the study. Patients will be treated and sourced from the public waiting lists in Western Australia. If the study concludes that the treatment is safe for patients, it will become available to the general patient population.

The manufacture of the product for the clinical trial will be conducted within the Orthocell clean room facilities according to Good Manufacturing Practice (GMP) code for human tissue manufacture. It is expected that the study will commence by September 2008 and run for 12 months.

Orthocell is also pleased to announce that it has been engaged to provide consultative services to Prince of Wales Hospital/Chinese University Hong Kong to assist them in the design and layout of a new GMP facility for research in the area of Stem cells. Orthocell will also be providing assistance in the development of their Quality Management System. It is hoped that this is the start of a long term collaborative relationship between the two parties.

Orthocell senior management have just returned from Bio 2008 where Professor M.H. Zheng (CSO) and Paul Anderson (CEO) presented on regenerative medicine ‘Opportunity Knocks’. The session focused on the development of the regenerative medicine genre and the burgeoning opportunities in this exciting sector and was well attended with positive feedback.

Finally Orthocell is delighted to welcome to its board of directors Professor Lars Lidgren professor of Orthopaedics at the University of Lund, Sweden. Professor Lidgren has authored and co-authored over 250 original publications, tutored 20 PhD students, and has more than 200 patents/applications. Currently he is Chairman for the Swedish National Knee Register, Director of the National Board of Health and Welfare, Musculoskeletal Competence Centre and member of several Editorial Boards.

He initiated a Bone and Joint Decade Consensus Meeting in Lund in 1998, which led to the worldwide Bone and Joint Decade 2000-2010, officially supported by the United Nations and launched by the WHO in January 2000. He is presently Chairman of the International Steering Committee.

Orthocell Pty Ltd (Orthocell) is a Biotherapeutic technology development company seeking to address unmet clinical needs within the global orthopaedics sector. Its core focus is biological therapies for tendon and ligament tissue repair and regeneration.

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