Title:
A pilot, masked, randomized clinical field study to evaluate the effectiveness of joint injection with bone marrow concentrate (BMC) compared to placebo for the control of pain associated with elbow osteoarthritis in dogs.
Investigators:
Valentine Verpaalen, DVM, MS, DACVS (Surgery Faculty)
If interested, please call the UGA Small Animal Teaching Hospital small animal referral coordinator at 706-542-5362.
Study Description:
For veterinary patients suffering from osteoarthritis associated pain, currently available treatments may lack effectiveness, or be associated with adverse effects if used for extended periods of time. Bone marrow concentrate (BMC) is a product made by concentrating bone marrow aspirate collected from a patient. The resultant concentrate contains stem cells and other factors that may control chronic inflammation and pain, and potentially even promote tissue healing. Intra-articular injection with BMC has shown promise for the treatment of osteoarthritis in people. Despite being commercially available for veterinary use, there are no clinical studies evaluating the use of BMC therapy for the treatment of canine osteoarthritis. The objective of this pilot study is to assess the effectiveness of BMC in dogs with naturally occurring arthritis of the elbow when delivered by intra-articular injection.
Inclusion Criteria:
- Dogs of any breed or sex, between 1 and 12 years of age and weighing at least 25 kg will be considered
- Observable predominant one-sided weight-bearing lameness localized to the elbow joint
- Elbow osteoarthritis (documented by radiographs)
- Medications to alleviate symptoms of OA ARE allowed provided dogs have received for 30 days prior to study initiation, and will remain on medications throughout study with no dose changes
Exclusion Criteria:
- Dogs cannot have received steroids or injectable polysuphated glycosaminoglycans (Adequan®) within the preceding 30 days
- Dogs cannot have had any medical or surgical procedure (including joint injections) within the preceding 90 days
- Dogs cannot have systemic or local disease other than osteoarthritis of the elbows
- Dogs cannot have any joint instability
Dogs with elbow arthritis meeting the above criteria will receive a baseline evaluation that includes the following: orthopedic examination by a board-certified veterinary surgeon and radiographs (x-rays) of the most affected elbow to document degree of elbow osteoarthritis. Dogs eligible for enrollment will be randomly assigned to one of two treatment groups: dogs that receive the BMC injection into the most affected elbow joint, and dogs that receive a placebo (saline) injection into the most affected elbow joint. On Day 0 of the study dogs will be sedated for administration of a single injection of the treatment to which it is assigned. Follow up appointments will be scheduled at 4, 8, and 12 weeks after treatment, and includes orthopedic evaluation and objective gait analysis. At each time point owners will be asked to fill out a questionnaire. Owners will also be provided with a logbook and will be instructed to maintain a record of any administered medications and potential adverse reactions. All procedures described above will be paid for by the study. Dogs assigned to the placebo group will have the opportunity to receive an active treatment of BMC at conclusion of the study, which would involve a similar follow up regimen with evaluation at 4, 8, and 12 weeks after treatment.
Potential Benefits to Veterinary Medicine:
Accurately assessing the efficacy of BMC may provide a promising alternative to chronic painful conditions such as osteoarthritis.
