Study Specifics
This GCP study conducted at multiple clinical study sites will evaluate the safety and effectiveness of a novel stem cell therapy preparation in cats with naturally occurring chronic kidney disease (CKD). The study veterinarian will administer the stem cell therapy by intravenous injection on Day 0 and 14. The study will compare the investigational veterinary product (IVP) to a placebo control product (CP). Cats at a given clinic will be randomly assigned to treatment group with a 2:1 group enrollment ratio. Follow-up visits/testing or phone follow-ups are required monthly. Throughout the study the owner will be required to observe and record any abnormal observations and assess food and water intake.
Funding
This is a fully funded study that includes seven scheduled clinic visits occurring at least once before treatment for screening (2 to 3 weeks prior), once for each treatment (Day 0 and 14), and four times thereafter (Days 30, 60, 90, 180). Funding includes the initial consultation, the study treatment and administration, recheck visits, and management of side effects that are thought to be directly related to participation in the study.
Eligibility
Cats that meet eligibility criteria and have a diagnosis of stage 2 or 3 CKD with no other diseases that would interfere with the study objectives, may enroll in the study. The study veterinarian will determine the stage of the cat’s kidney disease and discuss the complete list of study requirements.
Study Sites
Washington, DC
Bartlesville, OK
Franklin, IN
Pittsburgh, PA
Quakertown, PA
Fort Collins, CO
Zachary, LA
Additional study sites coming soon!
If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.
