Two years ago, VetCell Therapeutics USA announced that it had teamed up with Western University, College of Veterinary Medicine to conduct an investigational pilot clinical trial for canine atopic dermatitis. In this study, the two organizations set out to gain insight about the safety and effectiveness of using mesenchymal stem cell (MSC)-based therapy for treating canine atopic dermatitis (cAD). Today we can enthusiastically say that the study has concluded, and things are looking very promising.
We kicked this study off after our Investigational New Animal Drug (INAD) application and clinical trial protocol were filed with the Center for Veterinary Medicine (CVM), a branch of the US FDA. Filing an INAD application is the first step in beginning a clinical trial on an animal drug. While we are still on track to entering an FDA pivotal clinical trial, we wanted to utilize this study to bolster our understanding of various facets related to administering our cell treatment for cAD, including therapy transport and preparation procedures, dosing, cAD biomarkers, expected immune system response to MSC treatment and more.
During the course of the study, veterinary scientists at Western U were blinded to the data throughout the entire process. Now that the we have completed the trial and have unblinded the investigators, we are busy analyzing everything and hope to soon have the study results published in a major peer-reviewed journal. But we didn’t want to leave you guessing until then, so here are some of the things we’ve observed so far:
- No dogs experienced serious adverse events from subcutaneous administration of mesenchymal stem cells
- The treatments appear to have made a positive impact on the patients’ cAD symptoms, though our team is still analyzing the data to draw conclusions
- Phosphodiesterase 4D, miR-203, an imbalance between the Th1 and Th2 (CD4 + T helper subset cells), and selected cytokines in the peripheral blood are associated with the presence of atopic dermatitis in dogs, and in the future, these biomarkers may be used to help diagnose cAD
There are countless other exciting details that are still being learned as we get through the study data, but you will have to stay tuned as those will all be uncovered in the published study results.