A systematic review of decision-support tools for regenerative medicine

Abstract

Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain (mAb). Recent approved therapies in regenerative medicine have shown great clinical benefits to patients. This study investigates what are the decisional tools available and what issues and gaps have been raised for their use in regenerative medicine. We systematically searched the literature to identify publications on decision-support tools relevant to tissue engineering, cell and gene therapy, with the aim of identifying gaps for future decisional tool development. Identified papers have addressed key decisions in manufacturing and product development challenges in cell therapies. Our review has identified a limited number of decisional tools. There is ample space for expansion especially with regard to autologous cell therapies, tissue engineering and gene therapies.