A stem cell-based biopharmaceutical intended for use in treating degenerative joint diseases in dogs. Its active pharmaceutical ingredient is a suspension of allogeneic mesenchymal stem cells (MSCs).
The first stem cell-based biopharmaceutical for veterinary use developed by Bioceltix has been classified as a somatic cell therapy product. BCX-CM-J is currently the most advanced in terms of its TRL (Technology Readiness Level) – it is currently in its manufacturing process optimisation and quality assurance optimisation stages, and before the clinical trial and registration application stages. The active pharmaceutical ingredient of the product will be allogeneic mesenchymal stem cells isolated from the adipose tissue of eligible donors. The cells will be characterised according to their molecular phenotype, karyotype, microbiological purity, and other criteria.
BCX-CM-J will be manufactured as a suspension of allogenic mesenchymal stem cells (free from any microorganisms) intended for somatic cell therapy. The product will be administered via intra-articular injection. Its therapeutic indications (based on the current state of scientific knowledge and our observations) will include chronic inflammation of joints with early and advanced degenerative joint lesions (osteoarthritis) marked by pain and lameness. BCX-CM-J will be intended for use exclusively by a veterinary physician. The product is intended to be available off the shelf in deep-frozen form and ready to be administered directly after thawing.
Numerous studies have shown that the use of MSCs for the treatment of osteoarthritis in dogs results in a significant reduction of inflammatory infiltration, thus significantly alleviating pain and facilitating the activation of natural regenerative processes in the body.
Diseases of the musculoskeletal system are some of the most commonly diagnosed medical conditions in animals. Giant and fast-growing dog breeds, highly popular among breeders and animal owners, are particularly prone to developmental defects of the skeletal system – the most common of which are osteoarthritis (OA) and dysplasia.
According to the Animal Health Monitoring Systems Programme, more than 20% of dogs in USA alone suffer from degenerative joint lesions, which are considered to be the main cause of chronic pain in dogs. For many years, dysfunctions of the musculoskeletal system have been considered to be the predominant factor causing chronic pain in dogs. They are in the top ten diseases most commonly diagnosed in these animals.
Additionally, obese and older dogs are in a high risk group for osteoarthritis (it is estimated that two thirds of dogs over 7 years old suffer from OA), and the condition is much more severe than in younger dogs.
The chronic inflammation caused by osteoarthritis leads to a gradual degeneration of articular cartilage. The disease mainly affects the hip, stifle, shoulder, elbow, carpal, hock and intervertebral joints. The most important factors contributing to OA development include genetics (dysplasia), dog breed, age and body mass. The primary symptoms of OA are the discomfort of the animal caused by chronic pain and manifested by lameness, unstable and stiff gait, difficulty getting up from a resting position, reluctance to exercise, atrophy of hind limb muscles, and licking of sore joints. Symptoms of OA can appear in dogs of any age, both within several months or years of life.
The benchmark for treating osteoarthritis in dogs is based on non-steroidal and steroidal anti-inflammatory drugs, analgesics, and surgical procedures that prolong convalescence. These pharmaceutical therapies, commonly used by veterinarians, do not treat the cause of the disease – they only improve the well-being of the patient. There are many contraindications against the use of NSAIDs, including ulceration of the digestive tract, liver failure and renal failure. Pharmacotherapy requires routine check-ups (complete blood counts, blood chemistry). The long-term use of steroidal drugs often causes adverse reactions, including Cushing’s syndrome, diarrhoea, muscle atrophy, ulceration of gastric mucosa, and hepatitis.