Osteoarthritis Study Overview

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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