This week marks an exciting point in our collaborative clinical study with Western University of Health Sciences on the treatment of canine Atopic Dermatitis with adipose MSCs. The process of the study has been ongoing for the past couple of months. During that phase, several dogs with diagnosed atopic dermatitis were recruited to participate in the study.
The recruited participants were required to go through a controlled diet test to rule out any possible food allergies. There is a possibility that food allergies could mimic some of the inflamed and pruritic (itchy) dermal symptoms associated with AD. We conducted this test to rule out any potential cases where stem cells may not be beneficial and could in fact skew the trial’s results.
During this first phase of the trial, a couple of dogs did display a decrease in AD like symptoms after being on the controlled diet. This assured us that the protocol is working to rule out patients with food allergy dermatitis and that all recruited participants have an established case of atopic dermatitis and are ideal candidates for this stem cell therapy study.
The trail started with three of the participants receiving either of the dosage amounts that are being tested or a placebo. Each patient’s treatment remains unknown to the pet owners and clinical investigators as part of the double blinded study. This was a very exciting moment to be part of, since it was a highly involved process to finalize the coordination of both organizations’ teams and a considerable amount of time of research was utilized to make this product. This moment was so significant that both Dr. Chad Maki and Tom Ramos delivered the therapies to make sure nothing would deviate from the plan. We are also very thankful that the veterinarians at Western University, Dr. Kaur and Dr Clark, were also highly involved to ensure the clinical side runs smoothly.
The participants that had the first treatments were a pleasure to work with. The dogs were very well mannered as they endured multiple injections, which was a similar procedure as receiving multiple vaccinations. Following all injections, the progress was monitored closely over the course of many months for each of the participants to determine if the stem cells are offering relief from the inflammatory symptoms of dermatitis and if there are any unwanted side effects. Thus far, no negative side effects have been detected.
Prior to the injections, samples were taken from the participants to be analyzed in the lab of the principal investigator Dr. Jijun Hao, PhD, Assistant Professor at Western University. Dr Hao’s lab will be studying the immune cells and cytokines associated with the disease. This data will be instrumental to build the scientific case to support MSC treatment for atopic dermatitis.
Equally important in the success of a cell therapy is its freshness and viability. This experimental product was made at VetCell Therapeutics’ production facility in accordance with GMP regulations. The strategy for this project is to use a fresh, active version of an off the shelf cell therapy. It is a more involved procedure and the thought is related to the cells being more functional than an immediate application of thawed stem cells. It is still highly questionable whether thawed stem cells can ameliorate immune-mediated disease as compared to fresh stem cells.
The first steps had been taken for this lengthy trial. We will do our best to provide periodic updates and to discuss outcomes of the participant’s experiences.