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ArtiCell® Forte: The First Allogeneic Stem Cell Based Veterinary Medicine for Equine

More recently, in search for treatment alternatives, cell-based therapies are being investigated because of their biological nature and regenerative potential. Intra-articular application of mesenchymal stem cells (MSCs) improves cartilage healing supported by in vitro observations having demonstrated that chondrogenic induced MSCs produce cartilage-specific substances, such as aggrecan, glycosaminoglycans, and collagen type II, which may aid cartilage repair. In 2019, the European Medicines Agency has approved the first chondrogenic induced stem cell based veterinary medicine for the intra-articular treatment of mild to moderate recurrent lameness due to non-infectious joint inflammation in lower limb joints of horses. To develop ArtiCell® Forte, it was of utmost importance to understand the importance of the tissue sources of the stem cells but also the selection of donor horses to assure the generation of a relevant clinical effect based on immunogenic and chondroprotective properties. Based on the MUMS requirements applicable for this product in the EU, the safety and efficacy of the product was tested: 75 adult horses with early signs of degenerative fetlock joint disease were enrolled in a randomized, multicenter, double-blinded, and placebo-controlled study conducted in Belgium. Fifty animals were injected intra-articularly with ArtiCell® Forte (IVP), and 25 horses were injected with 0.9% NaCl (saline) solution. From week 3 to 18 after treatment, lameness scores (P < 0.001), flexion test responses (P < 0.034), and joint effusion scores (P < 0.001) were remarkably superior in IVP-treated horses. Besides nasal discharge in both treatment groups, no adverse events were observed. On long-term follow-up (1 year), significantly more ArtiCell® Forte treated horses were working at training level or were returned to their previous level of work (P < 0.001).

DATE » 25.08.2019

AUTHORS » Dr. Klaus Hellmann, Klifovet AG Collaboration with Global Stem cell Technology, Jan Spaas

PUBLISHED » One Health Research Symposium, August 25-26 2019, Kansas City Convention Center