Intralesional treatment of natural equine tendon disease with adipose derived mesenchymal stromal cells- controlled pilot study assessing the effect on the healing process

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Tendon disease is commonly accompanied by degenerative changes, making it a therapeutic challenge in equine practice as well as human orthopedic surgery. Aiming to improve the poor clinical results that are observed following conventional treatment, therapeutic approaches based on regenerative medicine have been pursued for several years. Particularly in equine practice, the local application of multipotent mesenchymal stromal cells is being widely used and represents the focus of many research projects.However, there is still no clinical study which could adequately confirm the efficacy of this therapeutic approach, hence the treatment is being performed based on very little evidence. Furthermore, in clinical settings, characterization of the applied cells is often neglected, despite the heterogeneity of the stromal cell populations used and the major importance of the cell characteristics with respect to therapeutic safety and repeatability of clinical results.Therefore, the aim of the proposed project is to establish a basis for a controlled clinical trial, which will allow an objective assessment of the efficacy of the cell therapy and which will permit an evidence-based therapy recommendation in the future. To achieve this goal, a controlled, randomized, triple-blind pilot study (12 animals per treatment group) will be performed. It will include a standardized recovery and characterization of allogeneic adipose derived stromal cells as well as a standardized treatment regime with regular follow-up examinations over a period of 12 months, with two university veterinary clinics being involved. Follow-up examinations comprise routine diagnostics such as clinical and ultrasonographic assessment as well as innovative non-invasive techniques such as gait analysis, ultrasonographic tissue characterization and low-field magnetic resonance imaging in order to obtain quantitative outcme parameters.The data obtained will be subjected to an explorative data analysis and used as a basis for the biometrical planning of a final clinical trial. The latter will include defined primary endpoints and involve further clinics and a higher number of cases in order to enable an objective evaluation of the efficacy of the cell therapy for tendon disease in horses. Thus, the proposed project is of direct clinical relevance for clinical veterinary medicine. Furthermore, it contributes to the development of regenerative therapies in human medicine.