Predicting Stem Cell Potency and Effectiveness (POTENCY)
The goal for this project is to create and qualify an off the shelf, assay platform that could be used to quantitatively predict potency/efficacy and toxicity of stem cell products before release to a patient. The long-term goal of the POTENCY Project Team will be to devise and validate relatively high throughput, high content, in vitro assays to test multiple samples/batches of stem cell products in parallel before they are considered further for use in animals or humans as potential regenerative cures
Issues Involved or Addressed
Development of cellular therapies for clinical use in animals and people involves a concerted effort by a sponsor to fully understand the final formulated product as it relates to identity, purity, sterility, stability and bioactivity. In particular, demonstration of potency (the dose needed to observe a desired response), and efficacy (whether the needed response is achievable at any dose that does not produce toxicity) are clearly defined by the FDA. As a first pass, we will focus on the development of a potency assay for a stem cell product used to treat cats with feline chronic gingivostomatitis (FCGS). As students learn more about the mechanisms that govern stem cell mediated regenerative processes, we will expand our approach toward the creation of a universal potency assay for human or animal stem cell products. This project requires a multidisciplinary team of mentors that will draw students with academic pursuits in molecular and cellular biology, biomedical engineering, biotechnology, and physiological sciences. The POTENCY project mentoring team will be drawn from faculty residing in the School of Veterinary Medicine, School of Medicine and College of Engineering.
Methods and Technologies
Academic Majors of Interest
Preferred Interests and Preparation
Students interested in stem cell technology and treatment protocols based on stem cells. Basic knowledge and experience with biochemistry, molecular biology, and chemistry principles and techniques is an added benefit.