Osteoarthritis Study Overview
Study overview for FDA Pivotal Study of Allogeneic Stem Cell treatment for Canine Osteoarthritis (INAD 012-234)
- This is the largest study of its kind to date, focusing on the treatment of canine arthritis utilizing stem cells
- This study is being sponsored by Animal Cell Therapies Inc. of San Diego CA and it is being overseen by the FDA Center for Veterinary Medicine
- There are a number of veterinary facilities in the United States participating in this study
- Only dogs over 1 year of age, exhibiting clinical symptoms of arthritis in no more than 2 joints (knees/hip/shoulders/elbows) will be considered for enrollment
- The study enrollment opens 3/1/2017 and is intended to be complete by late 2017
- Once a dog is qualified to participate, the study will last 6 months from the date of stem cell treatment
- Some dogs will initially receive a placebo injection. These dogs will have the chance to receive the actual stem cell injection(s) at the end of the study
- All expenses will be covered by the sponsor and qualified dog owners will be reimbursed up to $400 for study completion
- The Pet Stem Cell Institute finds its home in Saint Francis Pet Care Centers, owned and operated by Michael Amberry DVM of Tarpon Springs and Trinity FL
If you are interested this is what you need to do next
- Access our application page here to apply for the study and determine if you would like to enroll your dog
- Fill out and submit the online application and we will contact you to set up a screening appointment to determine if your dog will be admitted into the study
What would be expected of you if your dog meets the inclusion/exclusion criteria
- To bring him or her for the screening appointment. If accepted, laboratory samples and radiographs will be performed at this visit
- Two weeks later, an appointment will be scheduled where you would leave your dog with us for a portion of the day. It is at this appointment where he/she will receive her injection(s). A reversible sedative and local anesthetic will be administered to facilitate joint injections
- Three follow-up appointments, at 1 month, 3 months, and 6 months will be scheduled to evaluate your dog by exam and you will be required to fill out a brief survey. Note that the same person in the family is required to fill out all surveys and keep a home diary
- If your dog did not initially receive stem cells, it is at this time that we would schedule an appointment for him/her to have an injection(s) of stem cells like all the other participants