A new stem-cell based medicine has been given the go-ahead in the European Union for the treatment of horses with mild to moderate lameness due to joint inflammation.
Arti-Cell Forte is the first veterinary stem cell-based medicine to be authorised in the EU, for the reduction of mild to moderate lameness recurrent linked to joint inflammation in horses.
The product contains a type of stem cell obtained from equine blood — chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells — as the active substance. The product aims to activate chondroprotective mechanisms, such as producing extracellular matrix and influencing the inflammatory process in the joint.
It is available as a single injection into the affected joint. Stem cells are cells that can develop into different types of cells. The stem cells in the medicine are treated so that they develop towards cartilage cells which can assist in repairing damaged cartilage in the joint.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP)s recommended a marketing authorisation for Arti-Cell Forte late last month. A marketing authorisation is the approval to market a medicine in one, several or all European Union Member States.
In a field study conducted in horses with lameness of the fetlock joint, Arti-Cell Forte showed a statistically significant improvement in the horses treated with the medicine compared with a placebo control group six weeks after treatment. The positive effect of treatment was sustained over one year. In this study a single systemic administration of a nonsteroidal anti-inflammatory drug (NSAID) was given concurrently to treatment with Arti-Cell Forte.
The most common side effects were mild increase in lameness and injection site reactions in the first week after treatment.
The applicant for Arti-Cell Forte — Belgian company Global Stem cell Technology NV — sought scientific advice from the EMA during the development of the medicine. The CVMP opinion will now be sent to the European Commission for a decision on an EU-wide marketing authorisation.