Efficacy and safety study of allogeneic equine umbilical cord derived mesenchymal stem cells ( EUC-MSCs) for the treatment of clinical symptomatology associated with mild to moderate degenerative joint disease (osteoarthritis) in horses under field conditions

Laburpena

Osteoarthritis (OA) is one of the equine diseases with the greatest economic impact in the industry. Responsible for 60% of lameness, OA is considered one of the main causes of premature abandonment of sports life in horses. Despite its high economic impact on both direct and indirect costs, few new treatments have been developed for the treatment of equine OA in recent decades. Non-steroidal anti-inflammatory and / or corticosteroid accompanied by nutritional supplements are the most commonly used conventional treatments in the equine clinic, however, conventional treatments are associated with positive doping in sport horses and can have important medium-long term side effects. The objective of this work was to demonstrate the safety and efficacy of a new product of advanced therapies based on Equine Umbilical Cord Mesenchymal Stem Cells (EUC-MSC) as treatment of equine OA. To achieve the objective a superiority, controlled, blind, randomized and multicentre clinical study, has been designed and conduct following the European and Good Clinical Practices guidelines (VICH 9- GCP). In addition to the main objective, the present work has deep in the knowledge of the EUCMSC efficacy, for that different epidemiological covariates such as age, chronicity of symptoms, the type of joint affected or the degree of sporting level of the animal has been analysed in order to discover if there were specific equine populations where the EUC-MSC are not effective. Likewise, a comparative study on the efficacy-safety-price balance of the treatment with EUCMSC has been made in comparison with conventional treatments in order to discover if EUCMSC can be considered a real therapeutic alternative. The present study has demonstrated a robust efficacy of EUC-MSC in the reduction of lameness in horses affected by OA. 72% of the horses treated with EUC-MSC showed a reduction in the level of lameness, presenting non-lameness or an inconsistent lameness, allowing the horses to return to the same level of sport activity than after the injury. The study of epidemiological covariates found that the efficacy of EUC-MSC is consistent, not being affected by epidemiological factors such as age, chronicity of symptoms or the degree of sports activity. Finally, it has been established that in a comparative efficacy-safety-price chart, EUC-MSC represents a real alternative to conventional treatments thanks to its long efficacy and few adverse effects