Figure 1 schematically outlines the field of RM including different approaches, decision channels including public and private pathways, with technologies ranging from cellular-based approaches to tissue regeneration and organ building with further integration of acellular and scaffold/biomaterials components for diagnostic and therapeutic applications.
The RM field is rapidly evolving with a variety of adult and nonadult tissue resources and growing involvement of diversified players from academia, nonprofit, for-profit, regulatory, and government organizations.
RM has the capacity to address unmet clinical needs, and significantly improve on present therapies. These products will be developed as a result of therapeutic effectiveness, an adequate safety profile, and meeting regulatory requirements. The technology used in the products will dictate the development and manufacturing costs, the regulatory pathways, and the time taken to complete clinical trials, gain regulatory approval, and become commercialized.
All said, the RM portfolio is growing exponentially, but successful product outcomes are still difficult to predict. There is an ardent need for an effective metric system to identify and grade the probabilities, success potentials, and presumable pitfalls to validate RM treatments and technologies.