Cell therapies from both the maternal and fetal components of the placenta have the potential to treat numerous indications and to drive forward the field of regenerative medicine. However, the pipeline to successfully develop a placenta-derived cell therapy for clinical use and commercialization is complex and includes considerations involving numerous aspects of preclinical research and development, manufacturing, quality assurance, and clinical and regulatory considerations. In this chapter, we outline the main considerations and challenges involved in product development based on our experience in clinical development of placenta-derived cell therapies.