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VetVine Client Care
The Current Landscape Of FDA-approved Stem Cell Products In Veterinary Medicine
Regenerative Medicine
Regenerative medicine refers to therapies designed to repair, replace or restore damaged cells or tissues in the body. This is an area of medicine that is most exciting and innovative when it comes to treating disease in both humans and animals. Whereas many conventional therapies work to manage symptoms or suppress the body's natural response to disease or injury, regenerative medicine encourages healing from within and works by activating and supporting the body's own repair mechanisms. Approaches include cell-based therapies (e.g. stem cell therapy), blood-derived therapies (e.g. platelet-rich plasma (PRP)), engineered tissues and biomaterials (e.g. hydrogels), as well as gene and molecular therapies.
Stem cell therapy (mesenchymal stem cells) was first introduced into veterinary medicine over two decades ago for treating orthopedic conditions (e.g. equine musculoskeletal injuries and canine osteoarthritis). Since then, there has been an explosion in both interest and research into the application of stem cells for treating immune-mediated diseases, oral conditions, wound healing, and more!
No FDA-Approved Stem Cell Products (Yet)
Over the years consumers have been advised to be cautious when buying products in the health and wellness sphere (e.g. supplements), as many are not subject to regulatory oversight. As such, they have no guarantee in safety, quality control, third party testing to verify label claims, or efficacy. With the growing interest in stem cell therapy, we should all be asking: What stem cell products currently available on the market are FDA-approved?
Although there are a number of stem cell therapy products available for treating animals today, it may come as a surprise that none are actually FDA-approved. There are, however, companies working now to bring FDA-approved products to the marketplace. This means that the current market is still a bit of a "buyer beware" environment. Some companies are genuinely working to follow regulatory pathways and ensure their products are safe, effective, and consistent. Others may not be adhering to the same level of rigor. For veterinarians, this makes it especially important to evaluate products carefully and look for evidence of safety, consistency, and quality. FDA approval is not just a regulatory hurdle, it's a safeguard. An "approved" product must demonstrate:
- Safety - minimizing risks to patients
- Efficacy - proof that the therapy works as intended
- Consistency - each batch of cells is being produced to the same high standards
Reaching that point (obtaining FDA approval) takes time, resources, and strict adherence to protocols and reporting requirements during clinical research trials.
Looking Ahead
The future of stem cell therapy in veterinary medicine looks very promising. In early 2026, we expect to see the first allogeneic intravenous stem cell product (derived from healthy donors) come to market. While there are clinical research trials currently underway to determine efficacy for treating different diseases, the first FDA-approved application expected is for treating a very painful and debilitating disease of cats (feline chronic oral gingivostomatitis). For now, veterinarians and pet owners exploring stem cell therapies should exercise caution, ask the right questions, and critically assess the evidence behind each currently available option. Due to ongoing research and regulatory progress, we will soon see safe, effective, and FDA-approved stem cell therapies making their way into the veterinary space, transforming the way we treat a variety of conditions in our animal companions.