Photo courtesy Gallant Gallant, an animal health biotechnology company developing off-the-shelf mesenchymal stromal cell (MSC) therapies, announced that its canine osteoarthritis (OA) program has been granted eligibility for the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM)’s expanded conditional approval pathway, with potential conditional approval targeted for 2028. The announcement coincides with Arthritis Awareness Month and follows results from a randomized, blinded, placebo-controlled pilot study evaluating intravenous uterine-derived MSCs (UMSCs) in 88 client-owned dogs with naturally occurring OA. Dogs received two IV injections 14 days apart and were monitored through Day 90 using veterinarian assessments and validated pet owner-reported outcome measures. Dogs treated with UMSCs reportedly showed statistically significant improvements in mobility, pain, and quality-of-life measures at Days 60 and 90 compared with placebo. No treatment-related serious adverse events were reported, supporting repeat IV dosing safety. As reported by Gallant, OA affects more than 20 percent of dogs over one year of age, rising with age, and is driven in part by inflammatory and immune-mediated processes. Researchers involved in the program noted that MSC therapy targets these pathways and may influence disease progression, not only clinical signs. The IV delivery approach is designed to simplify administration in general practice compared with injecting into the joint(s) and requiring sedation or referral.
