Abstract
Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%, p = 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%, p = 0.017) and the veterinary global score (86.9 versus 30.8%, p = 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy.
Highlights
Canine osteoarthritis (OA) is a degenerative disease of all joint tissues, results in loss of articular cartilage, and has the hallmark clinical sign of pain [1]
This paper presents the results of a prospective, randomized, masked, placebo-controlled clinical study, designed to evaluate a target dose of a novel allogeneic, adipose-derived, Mesenchymal stem cells (MSCs) preparation for safety and efficacy in client-owned dogs with OA of one or two joints
The primary objective of this study was to confirm that a single dose of allogeneic, adipose-derived MSCs, delivered intraarticularly to either one or two joints, was significantly more effective than a placebo for treatment of OA in dogs
Summary
Canine osteoarthritis (OA) is a degenerative disease of all joint tissues, results in loss of articular cartilage, and has the hallmark clinical sign of pain [1]. The most clinically obvious pathologic changes in the joint are in the articular cartilage, a closer evaluation shows that the pathology encompasses the entire joint, including the synovium, tendons, ligaments, bone, and neural tissues [1]. NSAIDs are typically prescribed for a long duration, average owner compliance with prescriptions for daily NSAID administration may be poor [4], which leaves dogs with untreated clinical signs. Cell therapy relieves the owner of the burden of daily administration, may be associated with tissue regeneration, and should be investigated as a therapeutic solution. Allogeneic stem cells provide lower cost and off-the-shelf access that can result in a broader appeal and access
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