FDA Supervised Pilot Study for Diabetic Dogs
“Mesenchymal stem cell therapy of dogs with insulin-dependent type 1 Diabetes Mellitus”
Purpose of Study
The purpose of this study is to determine whether transplantation of insulin-producing canine mesenchymal stem cells is safe and effective in curing insulin-dependent diabetes mellitus, or significantly reducing your dog’s need for insulin. In addition, we wish to determine if this treatment can prevent or reverse diabetes-related organ damage for dogs treated with insulin. While this treatment has not yet been given to dogs, preclinical studies on rats and mice have shown these cells to be safe and effective in reversing insulin-dependent diabetes mellitus.
You will not be charged for any treatment associated with this study. The sponsor, SymbioCellTech, will pay for the diagnostic tests to see if your dog qualifies for this study and all treatment and follow-up related costs. You will be provided with a glucometer, a spring-loaded lancet device and sufficient test strips for monitoring glucose, as well as any needed insulin for your dog during the three-year follow-up period. In addition, you will receive mileage reimbursement, at $0.55/mile, to help cover study-related travel expenses to and from WSU’s Veterinary Teaching Hospital.
This study is accepting dogs that have been diagnosed with diabetes mellitus and are on an established insulin and diet plan to control their diabetes. Dogs can be any age as long as they are between 11-26 lbs. They should be healthy enough to undergo a brief period of heavy sedation or general anesthesia and be free of other systemic diseases. They should tolerate restraint for collection of blood and urine specimens, and tolerate blood glucose monitoring at home (you can watch YouTube videos for “at home glucose monitoring in dogs” to see what this entails). Dogs accepted into this study cannot be pregnant or have a history of cancer.
Prior to treatment, your dog will undergo a physical exam, an abdominal ultrasound and, if your dog is 9 years or older, he/she will receive chest x-rays to make sure there are no pre-existing abnormalities. Blood and urine samples will be taken and your dog will be assessed for the presence of cataracts, neurologic damage and other diabetes-specific organ damage.
On the day of treatment, your dog will either be briefly anesthetized or adequately sedated. Your dog’s abdomen will be shaved and sterilized and, using ultrasound guidance, a catheter will be used to slowly infuse insulin-producing, sterile cells into your dog’s abdominal cavity. Once treatment is completed, your dog will be carefully monitored until determined to be stable and fully awake. At that time, your dog will be allowed to return home with you.
Your dog will be followed for three years after treatment. You will be required to record your dog’s weight, blood sugar values, insulin dose and food and water intake on a pre-determined schedule. This study requires follow-up appointments at specific times when your dog will receive physical exams, blood testing, and other diagnostic tests necessary to assess how your dog is responding to therapy.
Owners need to be willing to bring their dogs to WSU’s Veterinary Teaching Hospital for a minimum of 17 visits over a 3-year period. They must be willing/able to use a glucometer to track their dog’s blood glucose levels at home and to fill out study-provided tracking sheets and other paperwork associated with the study. Owners are responsible for the costs associated with the initial diagnosis of their dog’s diabetes and the initial insulin and food required to get their dog’s diabetes under control.
For more information please contact Valorie Wiss, Clinical Studies Coordinator.
(Office: 509-335-0798, Cell: 509-432-5345 or firstname.lastname@example.org)