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Use of Intra-articular Autologous Protein Solution to Improve Lameness in Dogs with Osteoarthritis
Purpose of the study
The goal of this study is to evaluate the effectiveness of an autologous protein solution (APS) processing device to treat osteoarthritis (OA) in dogs.
Osteoarthritis (OA) is a debilitating joint disease affecting numerous dogs in the U.S. The bones within a moving joint are cushioned by cartilage, a fibrous tissue, and bounded by a sac of fluid called the synovial sac that keeps the joint lubricated and freely moving. Cells in the cartilage produce both the substances that comprised cartilage as well as the fluid of the synovium. These cells fail to function in osteoarthritis and that causes the space between the points to narrow often to a point where bones rub against one another. The process causes progressively increasing pain and lameness.
Although osteoarthritis is classified as a non-inflammatory disease, the inflammation process can affect the progression of the disease. As cartilage begins to breakdown, the ratio of naturally-occurring inflammatory to anti-inflammatory cytokines becomes imbalanced causing increased breakdown of cartilage. A novel method for up-regulation of anti-inflammatory cytokines from whole blood has been reported which produces an autologous protein solution (APS). This method has shown the ability to up-regulate anti-inflammatory cytokines from donor human, equine, and canine blood. Significantly, equine OA patients showed significant reductions in lameness after treatment with APS. The effectiveness of APS treatment has not been tested in canine OA patients. The following study is designed to test the ability of this method to up-regulate anti-inflammatory cytokines from canines with OA and determine if the solution can be used as an effective treatment for canines with OA.
- Have radiographically confirmed diagnosis of Osteoarthritis in either the stifle or elbow
- Demonstrate a dominantly unilateral load-bearing lameness referable to either the stifle or elbow joint
- Must be off all pain medications 1 week prior to appointment
- Weigh more than 11 kg
- Be between 1-12 years of age
- Otherwise medically healthy
- Any joint injections within 2 months of enrollment
- Previous plysulfated glycosaminoglycan (Adequan®Novartis) by any route of injection within 1 month
- Surgery within 3 months on the affected or contralateral joint
- Previous systemic steroid administration within 2 months
- Bone on bone contact on radiograph
- Intra bone fragments or fracture in the stifle joint
Study design/treatment schedule
Once your dog has enrolled into the study and you have signed the consent form, you will be responsible for maintaining appointments and filling out any required questionnaires. A single owner should fill out questionnaires over the course of the study. These questionnaires help the investigators to assess your dog’s level of discomfort associated with the arthritis. The study timeline is outlined below:
Day 1: Your animal will be physically examined then rated using two questionnaires (one for pain, which you will perform, and the other for lameness which one of the study investigators will score with your help). The force plate test will be performed by one of the study co-investigators. Thereafter, your animal will be sedated and about 2 tablespoons of blood will be drawn from the jugular vein. This volume is known to be safely withdrawn from animals the size of your dog. Synovial fluid will be withdrawn from the affected joint (the knee, called a stifle in the dog, or the elbow) to make room for the treatment to be administered. The synovial fluid samples will either be discarded, or may be saved for additional tests not planned for at this time. Then, your animal will be injected with either the control (saline) or the APS therapy.
You will be given simple instructions on how to care for your animal for the first day or two after the procedure. You will be asked to fill out two 11-item questionnaires for your return appointments. Finally, you will be asked to comply with the request to withdraw your animal from any pain medications and nutraceuticals 1 week prior to your appointments, if your animal needed them during this time. This is critical in order to determine the effectiveness of the therapy is not masked by pain medication.
Week 2 and Week 12: Your dog will be evaluated as described above using the questionnaires, physical examination, blood analysis and force plate analysis. At week 12, radiographs will be acquired and you will be informed as to whether your dog received the APS or the saline injection. If your dog received saline, then you will have the opportunity to have your dog injected with the APS therapy at this time.
- The costs for testing, sedation/anesthesia, and treatment will be paid for by the sponsor of this pilot study. That includes the physical exams, x-rays if necessary, and all biochemical and blood tests as well as the technology used to harvest your dog’s blood APS therapy.
- While any side effects of injection are unlikely, these could include swelling, inflammation and rarely, infection. The study does not cover costs for treatment of these complications.
- Upon completion of milestones in the study, the client will receive a debit card for $150. These milestones include completion of the 12-week evaluation at OSU and 24-week surveys, which will be mailed to OSU.
Nicole Stingle, RVT-614-688-5713 or Ashley Smith, RVT -614-292-4559