Klaus Hellmann

Managing Director
KLIFOVET AG

Bio: 

In the eighties, Klaus studied veterinary medicine followed by a thesis in applied biochemistry in boar reproduction at the Veterinary School in Hannover, Germany. From 1991 to 1994 Klaus worked at Pfizer, Germany. Since 1995, Klaus is consulting the industry regarding animal health, the development and registration of animal health products and plans, supervises and conducts safety and efficacy studies testing veterinary medicinal products in various animal species. Since 1997, he is the CEO of the contract research organisation and regulatory consultancy KLIFOVET AG, Munich, Germany, one of the leading organisations providing dedicated services to support new product development and registration for animals. He has extensive experience consulting all, multinationals, family businesses and start-ups how to develop animal health products and has led various Organisations to successful granting of marketing authorizations. Klaus is active in various animal health and veterinary organisations including the Association of Veterinary Consultants (AVC), the European College for Veterinary Pharmacology and Toxicology, member of AAVP, AAVPT and WAAVP and selected member of organisation committees of AAVM2014-2020 and acts regularly as organizer of conferences.

Abstract

ArtiCell® Forte: The First Chondrogenic Induced Stem Cell Based Veterinary Medicine for Horses

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).

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