VetCell Therapeutics and the College of Veterinary Medicine at Western University of Health Sciences have been diligently working together on a clinical trial for canine atopic dermatitis (AD) throughout the year. The major goal for this study is to determine if stem cell therapy helps patients gain relief from the inflammation caused by AD and to reduce the amount of constant scratching. This disease is prevalent in both dogs and humans and if the results are favorable, we hope this will help support potential human cell therapy applications for skin diseases.
Canine atopic dermatitis is a complex and multifactorial disease involving genetic predisposition, immune dysregulation, skin barrier defects, and oversensitivity to environmental allergens. AD affects approximately 10% of the canine population and results in a lot of discomfort for both dogs and pet owners. There is no single therapy which is completely effective, and this leads owners to try many different treatment options, which can be confusing. Stem cells are a potential option for treatment since the cells have specific roles in reducing inflammation and they have the ability to modulate the immune system.
Clinical grade mesenchymal stem cells are being researched by VetCell Therapeutics and Western U, regarding their role in modulating canine atopic dermatitis. The mechanism for AD is complex. It involves imbalance of the Th1/Th2 responses, a disturbed prostaglandin metabolism, intrinsic and defects in keratinocyte function. Although the mechanism of MSC immune modulation is not fully characterized, the current hypothesis supports the MSC functions of suppression against T- and B-cell proliferation. Additionally, MSCs promote the activity of regulatory T cells through cytokines or cell–cell contact mechanisms.
The current research project is a small-scale pilot study for proof of concept of the therapy. The study is enrolling 21 dogs to examine the safety and efficacy of canine MSCs. As of today, 14 of the 21 dogs are currently in the cell injection process and the remaining dogs will follow during the next 4-6 months. It is running very smoothly, both on our end and at the university. Thus far, the cells used in this study have not resulted in any serious adverse events once injected into the patients. This is a comforting result since the safety of stem cells is high on the FDA’s criteria list to focus on. Overall, our team has performed very well on this project and we have been consistent and successful in our cell therapy preparation and delivery.
The veterinarians at Western U have been pleased with how the product is delivered and presented for use. They report that some dogs have shown favorable results and have decreased itching. The veterinarians and pet owners are blind to the injections, so they do not know which pets have been given placebos or cell injections. On few dogs there were some reports of localized injection site swelling but it cleared within a week. Minor reports of such localized swellings and no reports of serious adverse events support the idea that subcutaneous administration of mesenchymal stem cells are safe for use in canine patients. This idea will continue to be tested throughout the study.
The initial gross clinical signs associated with atopic dermatitis have shown a positive response. We also have an interest in getting into the mechanism of the disease. Blood was collected from the patients and will be analyzed for any changes in the immune cells. When these results come in, they will be updated. Overall, we are pleased to report that the trial is going well, and the cells appear to be beneficial to the patients. We are looking forward to observing the next half of the patients and to dive into the mechanism of the disease.