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This course, focused on the practical application of the principles of
translating Stem Cell based therapies that focuses on the early
development and phase 1 studies required to translate these
interventions from the bench to the bedside. This course will highlight
the unique aspects of stem cell based therapies compared to drug
development.
Learning Objectives:
- Understanding to bench to bedside concept for Regenerative Medicine
- Understand the scope of Regenerative Medicine (e.g. what are stem cell versus cellular based therapies)
- Understanding the process of development of new stem cell based therapies
- Determining the preclinical work needed to support first-in-human studies
- Identify and describe the appropriate study design and methods
- Select a study population and methods for their recruitment and selection of study subjects for a stem cell study
- Describe methods of stem cell delivery and monitoring
- Understand Human Subjects issues for Regenerative Medicine studies
- Describe approval process for Regenerative Medicine products
- understand the purpose and structure of a targeted product profile
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