World Stem Cells and Regenerative Medicine Congress London 2013: An example of a successful regenerative medicine company is the Austalian Orthocell. The company formed in 2007 as a spun out from Western Australia University and is now successfully treating patients suffering from tendon, cartilage and soft tissue damage.
Initially focused on musculoskeletal regenerative medicine, Orthocell has now developed a scale up manufacturing for autologous tendon progenitors (tenocytes) cultivation and expansion process, as well as propriety collagen-based scaffolds, which are used alone or in a cell/matrix scaffold combination. They have established a variety of products and Paul Anderson, CEO at Orthocell, illustrated features and applications of one of these, which is the first product to be commercialized for autologous tenocyte implantation: Ortho-ATIâ¢. Ortho-ATIâ¢ is regulated in Australia as a cellular therapeutic and consists of an injectable cell suspension for tendon regeneration.
The market size is huge, with 11% of population seeking treatment for musculo-skeletal injuries such as tennis elbow and shoulder "rotator cuff" tendonitis every year. In the general routine, surgery is the ultimate clinical treatment for tendinopathies; it takes place only after the patient has undergone a painful weakness of the tendon and the surrounding tissues, due to the afunctional scar formation which is physiologically formed at the injured site as the result of the deposition of the wrong type of collagen. Current alternative therapies include exercise regimes, steroid, autologous blood or platelet rich plasma injection, but nor of these seems to be capable of triggering sustained and complete regeneration. At Orthocell they tried to use cell therapy to improve tendon healing and remodelling in tendinopathy.
Their rationale was firstly validated in a tendinopathic rabbit Achilles model, with very positive results: the autologous tenocytes were able not only to improve remodelling and tendon tensile strength, but also were integrated into the tendon matrix, actively participating in the tendon structural reconstruction1.
In human trials, the biopsy sampling is a 15-minute long, minimally invasive procedure, after which the tenocytes are expanded in culture and then reimplanted at the injuried site. Ortho-ATIâ¢ underwent all the phases of a rigid process characterization including safety, identity and potency throughout the whole bioprocess, until release into a phase I/IIa study for Lateral Epicondylitis. Safety, tolerability and efficacy were evident in all the patients, who were recruited only if their symptoms were present for over 30 months. 17 patients made it up to the 12-month follow up, and exhibited 93.7% improvement in movement, 87.3% pain reduction and 85.3% grip strength improvement, with all ameliorations being significantly present already one month after treatment.
The positive changes from baseline data allowed the indication expansion, with Orth-ATI TM being now tested in different countries also for Gluteal Tendinopathy (Phase I/IIa), Tendo-achilles RCT (Phase II / Level II), Rotator cuff RCT (Phase III / Level I).
1Jimin Chen, Qian Yu, Bing Wu, Zhen Lin, Nathan J. Pavlos, Jiake Xu, Hongwei Ouyang, Allan Wang, and Ming H. Zheng. Tissue Engineering Part A. August 2011, 17(15-16): 2037-2048. doi:10.1089/ten.tea.2010.0492.
By Giulia Detela