Animal health biotechnology company Gallant on Wednesday reported positive results from a pilot clinical study evaluating intravenous (IV) uterine-derived mesenchymal stromal cell (UMSC) therapy in cats with naturally occurring osteoarthritis (OA).

Additionally, the US Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM) has granted eligibility for the expanded conditional approval pathway for Gallant's feline OA therapy, allowing a faster pathway to market for a product that addresses a significant unmet medical need, ensuring target animal safety and cGMP-quality manufacturing while full effectiveness is being confirmed.

In a randomised, masked, placebo-controlled study across six US veterinary clinics, 35 client-owned cats with radiographically confirmed OA received two IV injections of either low-dose (5 million cells), high-dose (20 million cells), or saline placebo, administered 14 days apart. The cats were evaluated over 90 days by veterinarians and cat parents.

Overall, the pilot study findings support that IV UMSC therapy is well tolerated in cats with naturally occurring OA. Results showed statistically significant and clinically relevant improvement across both cat parent-reported and veterinarian-assessed outcomes.

The results of the 90-day study have been submitted for publication. A continuation study evaluating safety and efficacy of the low-dose therapy out to one year is ongoing.