BCX-CM-J
BCX-CM-J
A stem cell-based drug candidate intended for the treatment of degenerative joint disease (osteoarthritis, OA) in dogs. The active substance of the product is a suspension of allogeneic mesenchymal stem cells derived from adipose tissue. The product is intended for intra-articular injection. Therapeutic indications for the drug include chronic joint inflammation with early to moderate degenerative changes, manifested by pain and lameness in the animal.
Disease
Osteoarthritis (OA), through chronic inflammation, leads to gradual degeneration of the articular cartilage. It primarily affects the hip, knee, shoulder, elbow, carpal, tarsal, and intervertebral joints. The most significant risk factors for the development of OA include genetic predisposition (dysplasia), dog breed, age, and body weight. It is estimated that osteoarthritis affects approximately one in five dogs and as many as two-thirds of the canine population over seven years of age. OA is the leading cause of chronic pain in dogs. The main symptoms of disease progression include discomfort caused by pain, which manifests as lameness, unsteady and stiff gait, difficulty rising, and a general reluctance to engage in physical activity.
Existing treatment
Currently, the common treatment for osteoarthritis in dogs involves conventional chemical drugs based on non-steroidal and steroidal anti-inflammatory medications. These drugs primarily provide symptomatic relief, which limits their effectiveness, and chronic use can lead to numerous side effects such as Cushing’s syndrome, diarrhea, muscle atrophy, gastric mucosal ulcers, or hepatopathy.
Therefore, an alternative to chemical drugs are biologic drugs based on stem cells, which, in addition to symptomatic effects, demonstrate disease-modifying properties. This ensures higher efficacy and safety in the treatment of inflammatory conditions.
| Product | Species | Condition | Route of adminitration | Target Animal Safetyies | Pivotal study | Application to EMA | List of questions from EMA |
| BCX-EM |  |
OA | i.a. |  |
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Others
BCX-CM-AD
BCX-EM
