Autologous Stem Cell Therapy Trial for Atopic Dermatitis
ENROLLMENT CLOSED 3/28/17
The Veterinary Health Center at Kansas State University is currently enrolling cases for a regional (Manhattan, Kansas and Kansas City, Kansas and Missouri) clinical pilot study to evaluate safety and efficacy of autologous stromal vascular fraction (SVF, a cell therapy) in a FDA-reviewed investigation of new animal drug (INAD) for dogs with chronic, non-seasonal, not-food-related, atopic dermatitis.
All enrolled dogs will undergo a minor surgery to obtain abdominal fat (20-40g). Stromal vascular fraction (SVF) cells will be purified from the fat by MediVet Biologics. Your dog will return to the VHC to receive either SVF cell treatment or placebo control via intravenous injection. Your dog will return to the VHC for follow-up exams and blood sampling at 2, 4, 8, and 16 weeks post treatment. Your dog will wear a collar-mounted activity monitor continuously for 15 days prior to treatment and for 16 weeks after treatment. This monitor will measure your dog’s scratching activity. If your dog is not showing significant improvement 8 weeks after treatment, the group assignment will be unmasked and, if desired, your dog will be given a second SVF treatment.
Inclusion/ Enrollment criteria:
- Dogs (female or male) ranging in age 1-7 years old
- All breeds and weights will be considered
- Chronic dermatological skin allergy which is suspected non-seasonal, not food related with no known other health conditions
- Need to be under the care of attentive owners who agree, by signing an informed consent to participate in this clinical pilot study, to follow a set schedule of appointments at K-State and to observe their dog for the entire study period with reports of any adverse events promptly. May require 4-6 visits over a period of 45-60 days to the KSU veterinary teaching hospital.
- Evidence of cancer, history of cancer or concurrent disease, such as fungal, bacterial, or viral infection; malignant neoplasia; or any severe systemic disease that would confound interpretation of clinical effects.
- Dogs which cannot tolerate wearing an activity monitor
- Pregnant dogs or dogs that become pregnant will be excluded
Dogs will be enrolled based on the presence of chronic dermatological skin allergy which is non-seasonal, not-food related, with no other known health condition (1-4). Dogs may not be pregnant or become pregnant over the course of the study. Medium-sized breeds are preferred with body weights ranging from 30-80 lbs. All prospective patients will undergo routine physical, recording body weight, basic blood chemistry and CBC, chest and abdominal radiographs and evaluation of overall health. Since clinical signs overlap with other conditions, parasites, pruritic microbial overgrowth, food allergy and flea allergy will be excluded prior to enrollment using standard diagnostic or therapeutic methods. The clinical pruritus score assessed by a board-certified veterinary dermatologist using CADESI-4 and by the client using the VAS, will be 5 points or greater on the 9 point scale system.
All enrolled dogs will be deemed healthy with no systemic disease other than AD. Dogs that are on concomitant therapy, such as NSAIDs, specialized diets, will be required to stay on these medications at the same level throughout the study. Immune modulators such as corticosteroids, CsA, JAK inhibitors will be discontinued beginning 21 days before enrollment in the study and will not be administered during the study period. Dogs on ASIT for more than 1 year must stay on ASIT at the same dosing throughout the trial. Dogs that develop bacterial or fungal infections during the study may be treated while on the study. Dogs which cannot tolerate wearing the activity monitor collar will be excluded. Dogs which cannot tolerate being off immune modulators may be excluded.
All prospective patients will undergo routine physical, clinical chemistry and CBC, chest and abdominal radiographs and evaluation of overall health at the owner’s expense. All study-related activities are covered by study funds once your dog is enrolled into the trial.
For more information contact: Misty Bear, Clinical Trials Coordinator:
phone: (785)532-3046, email: Clinicaltrials@vet.k-state.edu