Restoring Health at the Source: Q&A With Dr. Linda Black DVM, PhD

Regenerative medicine is rapidly becoming a transformative force in both human and veterinary healthcare. One company at the forefront of this evolution in animal medicine is Gallant, an organization dedicated to bringing advanced, ready-to-use stem cell therapies into everyday veterinary practice.

Linda Black, DVM, PhD, Gallant’s CEO, has spent her career bridging science and clinical application. In this Vet-Advantage interview, Dr. Black explains how regenerative medicine works, why it offers a fundamentally different approach to treating disease, and how Gallant is working to make stem cell therapies accessible, scalable, and FDA-approved for the first time in veterinary medicine.

For starters, can you explain what regenerative medicine is, and how it works?

Dr. Black: By definition, regenerative medicine is a branch of medicine focused on repairing, replacing, and regenerating tissues to restore or establish normal function. The field of regenerative medicine is rapidly growing and contains several categories of innovation, including gene therapy, tissue engineering, and cell-based therapies, of which mesenchymal stem/stromal cells are common examples.

A key part of how regenerative medicine works is through immunomodulation – the ability to interact with the body’s own immune cells to reduce harmful inflammation and restore immune balance. Rather than simply masking symptoms, regenerative therapies aim to support the body’s intrinsic repair processes. By promoting tissue repair at the cellular level, these approaches offer the potential for true healing, allowing patients to not only feel better but actually get better.

Why is reducing inflammation critical to the healing process? What are some common ways this has been done in the past? How do these methods compare to regenerative medicine?

Dr. Black: The majority of illnesses are caused by an immune imbalance. Most inflammatory and autoimmune diseases, like osteoarthritis (OA), atopic dermatitis, and feline chronic gingivostomatitis (FCGS), are typically driven by a pro-inflammatory pattern of white blood cells and cytokines.

Currently, these diseases are managed by blocking inflammation. Standard treatments – NSAIDs, corticosteroids, monoclonal antibodies – work by suppressing specific inflammatory pathways. Imagine having an injured knee, taking an NSAID or other symptom-treating therapy, and going out to play on the injured knee because you cannot feel the pain. While these symptom-treating therapies can ease clinical signs and improve comfort, the underlying disease process often continues to advance. Veterinarians agree – today’s treatments primarily manage symptoms rather than addressing the root cause. The overwhelming majority of veterinarians said they’d be more likely to prescribe a therapy if it were disease-modifying, particularly for OA, chronic kidney disease (CKD), and FCGS, where current options fall short.

This is exactly where regenerative medicine offers a fundamentally new path forward. Mesenchymal stem cells (MSCs), which are the foundation of Gallant’s therapies, have powerful anti-inflammatory and immunomodulatory properties. They work naturally to restore immune balance and support tissue repair – targeting the root cause of disease, not just the symptoms.

What conditions are most commonly treated with regenerative medicine?

Dr. Black: In human medicine, MSCs have been studied in hundreds of clinical trials for a wide range of inflammatory and degenerative conditions – from osteoarthritis and Crohn’s disease to atopic dermatitis, kidney disease, and even neurological disorders like Parkinson’s and stroke. The first-ever FDA approval of an allogeneic stem cell therapy in human medicine was granted last December – a historic milestone for the field.

In companion animals, autologous and allogeneic stem cell therapy are being explored across a range of conditions, including FCGS, CKD, OA, atopic dermatitis, asthma, inflammatory bowel disease (IBD), and autoimmune encephalitis.

Real-world clinical use remains limited – largely because the only options until now have been autologous therapies, which are cumbersome, expensive, and out of reach for many practices.

Gallant is solving that accessibility gap with a pipeline of ready-to-use, allogeneic stem cell therapies targeting some of the most common and underserved diseases in pets. The pipeline includes FCGS, canine and feline OA, canine atopic dermatitis (CAD), and feline CKD. Gallant’s first product for refractory FCGS is on track for FDA conditional approval in early 2026. Our goal is to deliver the first-ever FDA-approved, ready-to-use stem cell therapy in veterinary medicine.

How has the adoption of regenerative medicine changed in veterinary practices over the last few years?

Dr. Black: According to the 2025 Brakke Consulting survey, about half of veterinarians are already using regenerative therapies in their practice. However, the majority of these are autologous methods.

Autologous therapy means the patient is the donor. It involves anesthesia and surgery to collect tissue from the patient, followed by shipment of the tissue out for processing. The volume and quality of stem cells are unpredictable. Autologous stem cell therapies are loosely regulated and simply not scalable. There are also concerns about using stem cells from an animal that is older or ill, as these factors greatly affect stem cell quality, quantity, and potency. Autologous stem cell therapy is considered the “old way.”
Allogeneic therapy – what Gallant is pioneering – is the new way. These therapies are ready-to-use and can be available on demand once FDA-approved. Harvested from FDA-qualified, healthy donors and manufactured in GMP-compliant labs, they are shipped frozen and can be thawed and administered as needed. No surgery, no anesthesia, no special equipment – just a simple slow IV injection.

Unlike autologous products, which have minimal regulatory oversight or published standards, allogeneic stem cell therapies are classified as drugs and must meet FDA requirements for safety, effectiveness, and manufacturing quality. These therapies are scalable, quality-controlled, and ready-to-use, representing a fundamentally new category in veterinary medicine.

What are the biggest barriers to wider use of regenerative therapies in animals?

Dr. Black: The biggest hurdle today is that there are currently no FDA-approved stem cell therapies in veterinary medicine. Without approved therapies, regenerative medicine has remained on the fringes – used inconsistently and without clear standards. The first FDA approval will be a major milestone, signaling that stem cell therapy is no longer niche – it’s real, regulated medicine that’s finally ready to go mainstream. And as more FDA-reviewed products reach the market, adoption will accelerate.

The second challenge is education. Awareness of regenerative therapy is still relatively low across the profession, and there are lingering misconceptions – from how it works to who can use it. As with any new category, it takes time to build comfort and clinical confidence.

This isn’t just a new therapy – it’s a true shift in how we think about disease. We’re not managing symptoms anymore. We’re restoring health.

What advances or innovations do you foresee in regenerative veterinary medicine over the next 5-10 years?

Dr. Black: We anticipate that veterinary medicine will continue to mirror the trajectory we’re seeing in human healthcare, with a rapid increase in studies evaluating the use of MSCs and other regenerative therapies across a wide range of conditions. The FDA approval of the first allogeneic MSC therapy will be a monumental milestone – one that paves the way for more ready-to-use stem cell therapies to follow.

These therapies won’t just add new tools to the veterinary toolbox – they will fundamentally change how we approach disease itself. Stem cell therapy should not be seen as a “last resort” or alternative approach. On the contrary, earlier treatment with MSCs may reduce inflammation and promote tissue repair, helping to slow or prevent disease progression.

Stem cell therapy is no longer futuristic or experimental. It’s here – and it’s being held to the same standards as any other veterinary drug. With continued research and FDA-reviewed pathways, regenerative medicine is on track to become a mainstream standard of care – accessible, scalable, and available to any pet that needs it.

Photos courtesy of Gallant