- 76% of treated cats showed improved quality of life vs. 36% placebo
- IV uterine-derived MSC therapy demonstrated strong safety and tolerability
- FDA-CVM grants eligibility for expanded conditional approval pathway
- Study supports potential disease-modifying approach vs. symptom management
- Continuation study underway to assess 1-year durability
Gallant announced positive pilot study results for its intravenous uterine-derived mesenchymal stromal cell (UMSC) therapy targeting feline osteoarthritis (OA), alongside receiving eligibility from the FDA’s Center for Veterinary Medicine for the expanded conditional approval pathway.
Osteoarthritis affects up to 90% of older cats and is associated with chronic pain, reduced mobility, and diminished quality of life. Current therapies largely focus on managing inflammation and pain, rather than addressing underlying disease mechanisms.
In the randomized, masked, placebo-controlled study conducted across six U.S. veterinary clinics, 35 client-owned cats with radiographically confirmed OA received two IV injections—either low-dose, high-dose, or placebo—administered 14 days apart. Outcomes were assessed over a 90-day period by both veterinarians and cat owners.
Results demonstrated statistically significant improvements across multiple endpoints. At three months post-treatment, 76.2% of treated cats showed improvement in quality of life based on owner-reported measures, compared to 36.4% in the placebo group. Veterinarian assessments also showed improvement in pain scores (81% vs. 45.5%) and overall quality of life (60% vs. 20%).
The therapy was reported to be well tolerated, with findings supporting both safety and clinical relevance. The data have been submitted for publication, and a continuation study is ongoing to evaluate long-term safety and efficacy over one year.
The FDA-CVM’s decision to grant eligibility for the expanded conditional approval pathway allows Gallant to pursue a faster route to market while continuing to confirm full effectiveness, provided safety and manufacturing standards are met.
Gallant’s approach leverages the immunomodulatory properties of mesenchymal stromal cells, which may address the root cause of osteoarthritis rather than only alleviating symptoms. This positions the therapy as a potential disease-modifying option in feline medicine.
The company continues to emphasize feline-focused innovation, an area historically underserved in veterinary therapeutics. The OA program builds on Gallant’s broader pipeline, which includes additional indications such as feline chronic kidney disease, canine osteoarthritis, and dermatologic conditions.
Gallant is also advancing sonruvetcel, a stem cell therapy for refractory feline chronic gingivostomatitis, which is expected to potentially become the first FDA-approved off-the-shelf IV stem cell therapy for cats later this year.
Information sourced from the company’s press release.
