Veterinary FAQ: Stem Cell Therapy for Pets
We’ve compiled answers to the most common questions about stem cell therapy. Don’t see your question on our list? Please get in touch – we’re here to help.
Stem cells are unique cells with the ability to develop into various specialized cell types in the body. They also have the capacity for self-renewal, meaning they can divide to produce more stem cells. Stem cells are generally categorized into two main types: embryonic stem cells, which can become almost any cell type, and adult stem cells, which are more limited and typically generate the cell types found in their tissue of origin. Due to ethical concerns, embryonic stem cells are rarely used. In both human and veterinary medicine, the vast majority of stem cell therapies rely on adult stem cells. The most common adult stem cell is the mesenchymal stem cell, also called a mesenchymal stromal cell (MSC). MSCs work primarily through immunomodulatory mechanisms rather than cell regeneration.
The primary mode of action of MSCs is to regulate the dysregulated immune system thereby reducing inflammation and supporting tissue repair. MSCs respond to chemical signals released by damaged or stressed tissues and migrate through the bloodstream to the diseased site. Once there, MSCs work in coordination with the body’s own cells to modify the disease process including to promote healing and restore function, naturally.
MSCs target the root causes of disease rather than just treating symptoms. They can detect areas where biological processes are disrupted and communicate with local host cells to help restore normal function. Immune dysregulation is at the root all disease, and MSCs target different pathways depending on the underlying disease process. MSCs may not only control clinical signs but also impact disease progression and tissue repair.
MSCs respond to signals from injured or diseased tissues, enabling them to migrate, or “home,” to the areas in the body where there is active immune dysregulation and inflammation.
Human and veterinary stem cell therapies are treated similarly. The type of cell, mode of administration, dosing, and indication are all based on how the cells are studied and approved in humans and animals. Veterinary cell therapies are held to the same high standards as human cell therapies; both go through a rigorous FDA approval process to ensure sterility, purity, potency, stability, safety, and efficacy.
MSCs are being studied across various species for multiple diseases. Effectiveness between species cannot be compared and is dependent on the disease being studied as well individual patient response to therapy. Efficacy studies with sound statistical analysis are necessary to substantiate any efficacy claim.
Gallant is developing FDA-regulated, allogeneic MSC therapies from the uterine tissue of healthy FDA-qualified donor animals. Product is able to be held in inventory or shipped on demand.
Gallant’s product is an allogeneic (different donor and recipient animal) mesenchymal stem cell product derived from uterine tissue, manufactured under stringent quality control conditions. Unlike autologous (same donor and recipient animal) MSCs that require harvesting cells from a potentially older or sick animal, our standardized donor-derived approach allows for on-demand treatment with consistent, high-quality, potent cells with demonstrated safety and efficacy.
Gallant is conducting multiple clinical trials evaluating feline chronic kidney disease, canine atopic dermatitis, and canine and feline osteoarthritis. Results of Gallant clinical trials in refractory feline chronic gingivostomatitis (FCGS) support the safety and efficacy of stem cells for refractory FCGS, and Gallant is on track for conditional FDA approval of a product to target refractory FCGS in 2026.
Gallant’s therapies are regulated by the FDA’s Center for Veterinary Medicine (CVM). This pathway requires demonstration of safety, efficacy, and manufacturing quality through controlled clinical trials. Our development process follows the FDA’s phased approach: safety and efficacy studies conducted as both pilot and pivotal studies that may be a combination of laboratory and client-owned field studies. Gallant is fully committed to obtaining FDA approval for targeted indications.
There are no studies directly comparing MSCs to other therapies in the same population. The major difference between MSCs and other therapies is that most medications work to manage symptoms by reducing pain and inflammation. MSCs are a potentially disease modifying therapy where they work with the body’s cells to promote natural healing and repair rather than just treating the symptoms. MSCs may also be effective with other therapies rather than being considered an alternative therapy.
The manufacturing facility adheres to current Good Manufacturing Practices (cGMP), which are the standards followed by drug manufacturers producing FDA-regulated products.
Unprimed uterine-derived mesenchymal stem cells (UMSCs) are in a natural state after being collected and expanded from donor tissue without further manipulation. Primed UMSCs, on the other hand, have been exposed to specific growth factors, cytokines, or other bioactive compounds to enhance certain therapeutic properties before being frozen.
Please contact us at info@gallant.com and we’ll be happy to put you in touch with our clinical trials team to discuss whether your clinic meets the site and staff requirements to become a clinical trial site.
Please contact us at info@gallant.com and we’ll be happy to put you in touch with our clinical trials team to discuss whether your clinic meets the site and staff requirements to become a clinical trial site.
Clinical trials are conducted at no cost to you or your clients. Gallant’s clinical trials are fully funded with study budget allocation varying depending on the study and the site. Please contact us at info@gallant.com and we’ll be happy to with our clinical trials team to discuss specifics.
Clinical sites receive comprehensive support from our clinical research team throughout the process that includes remote and on-site training, educational materials, ongoing study support for data and query resolution, and case recruitment. Please contact us at info@gallant.com and we’ll be happy to put you in touch with our clinical trials team to discuss more details.
